Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. There are no adequate and well-controlled studies in pregnant women treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Therefore, it should be used with caution in patients receiving such agents. Not only a simple moisturizer but knows much more: keeps the skin lipids between our skin cells in a healthy (liquid crystal) state, protects against irritation, helps to restore barrier Effective from as low as 3% with even more benefits for dry skin at higher concentrations up to 20-40% This Patient Information has been approved by the U.S. Food and Drug Administration. Fertility studies in rats treated orally with up to 300 mg per kg per day of clindamycin (approximately 120 times the amount of clindamycin in the highest recommended adult human dose of 2.5 g Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, based on mg per m 2) revealed no effects on fertility or mating ability. We understand the importance of empowering physicians and patients by providing access to the highest quality products. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. 68682-0409. You and your healthcare provider should decide if you will use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% while breastfeeding. Last updated on May 1, 2021. The labeler has 105 products that have an assigned National Drug Code. Call your doctor for medical advice about side effects. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may cause skin and facial hair to temporarily change color (yellow/orange) when used with topical sulfone products. Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USAManufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada, U.S. Patent Numbers: 8,288,434; 8,663,699; 8,895,070; 9,078,870; 10,220,049 and 10,624,918, 2020 Bausch Health Companies Inc. or its affiliates, PATIENT INFORMATION Clindamycin Phosphate and Benzoyl Peroxide gel, 1.2%/2.5%. Important: For use on the skin only (topical use). CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE- clindamycin phosphate and benzoyl peroxide gelOceanside Pharmaceuticals. Table 1. Before using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, herbal supplements, and skin products you use. Medically reviewed by Drugs.com. WARNING. Microbiology: Although clindamycin phosphate is inactive invitro, rapid invitro hydrolysis converts this compound to clindamycin, which has antibacterial activity. Chemically clindamycin phosphate is C 18 H 34 CIN 2 O 8 PS. Clindamycin when taken by mouth or by injection has been reported to appear in breast milk. Clindamycin Phosphate Topical Gel is indicated for topical application in the treatment of acne vulgaris. For more information, call 1-833-285-4151. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. The carcinogenicity of a 1% clindamycin phosphate gel similar to Clindamycin Phosphate Topical Gel was evaluated by daily application to mice for 2 years. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a prescription medicine used on the skin (topical) to treat inflamed acne in people 12 years and older. It may harm them. 100 mL. Orally and parenterally administered clindamycin has been associated with severe colitis, which may result in patient death. Concomitant topical acne therapies should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Oceanside Pharmaceuticals Tretinoin Gel Microsphere, 0.1% ingredients 200 Meredith Avenue, Suite 101A Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, a white to off-white smooth gel is supplied as: NDC 68682-132-50 50 g pump. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with Clindamycin Phosphate and Benzoyl Peroxide Gel [see Postmarketing Experience (6.2)]. Oceanside Pharmaceuticals. Benzoyl peroxide in acetone at doses of 5 and 10 mg administered twice per week induced squamous cell skin tumors in transgenic TgAC mice in a study using 20 weeks of topical treatment. Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), announced on October 17, 2022, a Medical Device Correction for all Omnipod DASH Personal Diabetes Managers (PDMs) distributed globally. Oral: Reduced rate of absorption with food. Percent reductions in inflammatory lesion counts after treatment for 11 weeks in these 5 trials are shown in Table 2. If you would like more information, talk with your healthcare provider. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chloro-substitution of the 7 (R)-hydroxyl group of the parent antibiotic lincomycin. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a fixed combination product with two active ingredients in a white to slightly yellow, opaque, aqueous gel formulation. Inactive ingredients: carbomer homopolymer (type C), dimethicone, edetate disodium, glycerin, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide. Clindamycin Phosphate/ Benzoyl Peroxide. Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel in your mouth, eyes, or vagina. Clindamycin binds to the 50S ribosomal subunits of susceptible bacteria and prevents elongation of peptide chains by interfering with peptidyl transfer, thereby suppressing protein synthesis. These are not all of the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel. Privacy Policy | Copyright 2022. In one 12-week multicenter, randomized, evaluator-blind, vehicle-controlled, parallel comparison clinical trial in which patients used Clindamycin Phosphate Topical Gel, 1%, once daily or the vehicle gel once daily, in the treatment of acne vulgaris of mild to moderate severity, Clindamycin Phosphate Topical Gel applied once daily was more effective than the vehicle applied once daily. Genotoxicity tests performed included a rat micronucleus test and an Ames Salmonella reversion test. Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to your face 1 time a day, in the evening or as directed by your healthcare provider. Active ingredients: clindamycin phosphate 1.2% and benzoyl peroxide 5%. This site complies with the HONcode standard for trustworthy health information: verify here. Clindamycin Phosphate and Benzoyl Peroxide Gel may affect the way other medicines work and other medicines may affect how Clindamycin Phosphate and Benzoyl Peroxide Gel works. Safely throw away expired Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin injection and may range in severity from mild diarrhea to fatal colitis. DailyMed - CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE gel Clindamycin Phosphate and Benzoyl Peroxide Gel is a, Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e. Chemically clindamycin phosphate is C 18 H 34 CIN 2 O 8 PS. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility. Mean Percent Reduction in Inflammatory Lesion Counts. These medications may be counterfeit and potentially unsafe. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7 (S)-chloro-substitution of the 7 (R)-hydroxyl group of the parent antibiotic lincomycin. To minimize exposure to sunlight, a hat or other clothing should be worn. Studies indicate toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. 400 Somerset Corp Boulevard Bridgewater, NJ 08807 (908) 927-1400. Do not get Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% on cuts or open wounds. (Percentages derived by number of subjects receiving Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% with symptom score/number of enrolled subjects receiving Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%). Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel if you have: Before using Clindamycin Phosphate and Benzoyl Peroxide Gel, tell your doctor about all of your medical conditions, including if you: Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. C-1, Madkaim Industrial Estate, Madkaim, D10AF51 Clindamycin, combinations D10602 Clindamycin phosphate and benzoyl peroxide <JP/US> USP drug classification [BR:br08302] Dermatological Agents Acne and Rosacea Agents Acne and Rosea, Other Clindamycin/ Benzoyl Peroxide D10602 Clindamycin phosphate and benzoyl peroxide Therapeutic category of drugs in Japan [BR:br08301] 2 Agents . Who should not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? The clindamycin and benzoyl peroxide components individually have been shown to have in vitro activity against Propionibacterium acnes, an organism which has been associated with acne vulgaris; however, the clinical significance of this in vitro activity is not known. The skin should be gently washed, rinsed with warm water, and patted dry before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. USP drug classification [BR: br08302] Dermatological Agents. A comparative trial of the pharmacokinetics of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and 1% clindamycin solution alone in 78 subjects indicated that mean plasma clindamycin levels during the 4-week dosing period were less than 0.5 ng per mL for both treatment groups. OVERDOSAGE Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Do not give Clindamycin Phosphate and Benzoyl PeroxideGel, 1.2%/5% to other people, even if they have the same symptoms you have. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 10 mg (1%) clindamycin, as clindamycin phosphate, and 50 mg (5%) benzoyl peroxide in a base consisting of carbomer homopolymer (type C), dimethicone, edetate disodium, glycerin, poloxamer 182, purified water, silicon dioxide, and sodium hydroxide. Clindamycin Phosphate and Benzoyl Peroxide (Oceanside Pharmaceuticals During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. KEGG DRUG: Clindamycin phosphate and benzoyl peroxide seizure clusters, acute repetitive seizures) that are, Carefully consider the potential benefits and risks of diclofenac sodium extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release, Sun, 06 Nov 2022. Recall: Clindamycin/Benzoyl Peroxide for Acne - GoodRx Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is contraindicated in those individuals with a history of regional enteritis, ulcerative colitis, pseudomembranous colitis, or antibiotic-associated colitis [see Warnings and Precautions ( 5.1)]. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. Treatment should be discontinued if the irritation persists. Company profile page for Oceanside Pharmaceuticals Inc including stock price, company news, press releases, executives, board members, and contact information Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. There are reports of an increase of P. acnes resistance to clindamycin in the treatment of acne. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. Sunscreen may also be used. Oceanside Pharmaceuticals Inc - Company Profile and News Severe colitis may result in death. Oceanside Pharmaceuticals. Less than 2% of the dose enters systemic circulation as benzoic acid. Clindamycin Phosphate and Benzoyl Peroxide, % of Subjects Using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% with Symptom Present, Table 2. CLINDAMYCIN PHOSPHATE- clindamycin phosphate gelOceanside Pharmaceuticals. Browse our full selection of products and order online. Benzoyl peroxide is an oxidizing agent with bacteriocidal and keratolytic effects, but the precise mechanism of action is unknown. Thornton, Colorado, Adams Polishes, LLC is voluntarily recalling lot 133475 of Adams Polishes Hand Sanitizer to the consumer level. Clindamycin Phosphate and Benzoyl Peroxide Gel is a Oceanside Pharmaceuticals 30 September 2020 Diazepam Package/Label Display Panel Carton - CLINDAMYCIN PHOSPHATE TOPICAL GEL Advise the patient to read the FDA-approved patient labeling (Patient Information). Oceanside Pharmaceuticals - List of Drugs - NDC Labeler/Manufacturer More Info Diltiazem Hydrochloride. Oceanside Pharmaceuticals 1 INDICATIONS AND USAGE Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Avoid using tanning beds or sun lamps. Available for Android and iOS devices. Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. This medication is used to treat a certain type of vaginal infection (bacterial vaginosis) in women who are not pregnant. Encube Ethicals , Inc. During clinical trials, 397 subjects used Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% once daily for 11 weeks for the treatment of moderate to moderately severe facial acne vulgaris. How should I use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? For more information about Clindamycin Phosphate and Benzoyl Peroxide Gel, call 1-800-321-4576. Wash your hands with soap and water after applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Clindamycin Phosphate 1.2% and Tretinoin 0.025%, Clindamycin Phosphate and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Perrigo Pharmaceuticals has voluntarily recalled their clindamycin/benzoyl peroxide (1.2%/5%) gel, due to the presence of a small amount of mold on the caps of the tubes. Clindamycin Phosphate 1.2% and Tretinoin 0.025%. Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. The following adverse reactions have been identified during postapproval use of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. The structural formula for clindamycin is represented below: Chemical Structure - benzaclin gel 01 Clindamycin Phosphate. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% passes into your breast milk. In patients with P. acnes resistant to clindamycin, the clindamycin component may provide no additional benefit beyond benzoyl peroxide alone . Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% should be used with caution in patients receiving such agents. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. Studies indicate a toxin(s) produced by Clostridia is one primary cause of antibiotic-associated colitis. Shop Henry Schein Medical for the best selection in Rx. Oceanside Pharmaceuticals Bridgewater NJ, 08807 - Manta.com [See Adverse Reactions ( 6.2).]. 2 DOSAGE AND ADMINISTRATION Before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. 611 Acting mainly on gram-positive bacteria. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Studies have not been performed with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% or benzoyl peroxide to evaluate the effect on fertility. ALISO VIEJO, Calif., Nov. 23 /PRNewswire-FirstCall/ -- Oceanside Pharmaceuticals, part of Valeant Pharmaceuticals International (NYSE: VRX), today announced that it has now launched chlordiazepoxide hydrochloride and clidinium bromide, an authorized generic (AG) version of Librax. This Patient Information has been approved by the U.S. Food and Drug Administration. Visit Website. The primary efficacy measures were the lesion counts and the investigator's global assessment evaluated at Week 11. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. More Info Urolet Mb More Info Prednicarbate More Info Metronidazole Gel More Info Erythromycin And Benzoy. 68682-0300. D10602 Clindamycin phosphate and benzoyl . See the end of this leaflet for a complete list of ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Using other topical acne products may increase the irritation of your skin when used with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Avoid the eyes, mouth, lips, mucous membranes, or areas of broken skin. Clindamycin Phosphate and Benzoyl Peroxide (Oceanside Pharmaceuticals How should I store Clindamycin Phosphate and Benzoyl Peroxide Gel? Within the Prescription Medications section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Patients who develop allergic reactions such as severe swelling or shortness of breath should discontinue use and contact their physician immediately. You can also ask your pharmacist or healthcare provider for information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% that is written for health professionals. https://medlibrary.org/lib/rx/meds/clindamycin-phosphate-22/. Accord Healthcare, Inc., the US subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company headquartered in Durham, North Carolina. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 2 DOSAGE AND ADMINISTRATION This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. Durham, NC 27713 USA, PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Package insert / prescribing information More Info Omeprazole And Sodium B. D10AF Antiinfectives for treatment of acne. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older. Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. NDC 68682-190 Clindamycin Phosphate And Benzoyl Peroxide The following selected adverse reactions occurred in less than 0.2% of subjects treated with Clindamycin Phosphate and Benzoyl Peroxide Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). Clindamycin Phosphate and Benzoyl Peroxide Gel may bleach hair or colored fabric. Do not freeze Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. 800-438-2568 Do not get Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% in your mouth, eyes, vagina or on your lips. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088. Talk to your doctor about any side effect that bothers you or that does not go away. Avoid the eyes, mouth, mucous membranes, or areas of broken skin. What is Clindamycin Phosphate and Benzoyl Peroxide Gel? Home | Bausch Health Combined Results from the Two Phase 3 Trials (N = 773), Oceanside Pharmaceuticals product information by RSS, Clindamycin Phosphate and Benzoyl Peroxide, Additional medications in the Prescription Medications section by. Clindamycin Phosphate Topical Gel, 1%, a topical antibiotic, contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram in a gel vehicle consisting of carbomer 941, methylparaben, polyethylene glycol 400, propylene glycol, purified water, and sodium hydroxide. You can also ask your doctor or pharmacist for information about Clindamycin Phosphate and Benzoyl Peroxide Gel that is written for healthcare professionals. No significant increase in tumors was noted in the treated animals. When significant diarrhea occurs, the drug should be discontinued. Genotoxicity studies were not conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. 2634 Antibiotics for external use. It has the following structural formula: Benzoyl Peroxide has a molecular weight of 242.23. In five randomized, double-blind clinical trials of 1,319 subjects, 397 used Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 396 used benzoyl peroxide, 349 used clindamycin, and 177 used vehicle. Following multiple applications of Clindamycin Phosphate Topical Gel less than 0.04% of the total dose was excreted in the urine. Ltd. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is not for oral, ophthalmic, or intravaginal use. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% may cause serious side effects, including: o swelling of your face, eyes, lips, tongue, or throat. Especially tell your healthcare provider if you take a medicine that contains erythromycin. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. What are possible side effects of Clindamycin Phosphate and Benzoyl Peroxide Gel? About Contact Details Reviews. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. manufacture(21922-022), analysis(21922-022), pack(21922-022), label(21922-022), 45 gram tube NDC 21922-022-06. Clindamycin Phosphate and Benzoyl Peroxide Gel is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older. Do not get Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% in your mouth, eyes, nose, vagina, or on your lips. Each gram of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% contains 12 mg clindamycin phosphate (equivalent to 10 mg of clindamycin) and 50 mg benzoyl peroxide. KEGG DRUG: Clindamycin phosphate and benzoyl peroxide Clindamycin is a lincosamide antibacterial [see Clinical Pharmacology ( 12.4)]. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel is safe and effective in children under 12 years of age. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing. Plot No. What are the ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel? Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% if you have: What should I tell my healthcare provider before using Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? Adams Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol, Insulet Issued Voluntary Medical Device Correction for Omnipod DASH Personal Diabetes Manager on October 17, 2022. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. In a contact sensitization study, four of the 200 subjects appeared to develop suggestive evidence of allergic contact sensitization to Clindamycin Phosphate Topical Gel. Keep Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and all medicines out of the reach of children. The clinical significance of this in vitro antagonism is not known. Subjects were instructed to wash the face, wait 10 to 20 minutes, and then apply medication to the entire face, once daily in the evening before retiring. Because many drugs are excreted in human milk, caution should be exercised when Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is administered to a nursing woman. Both tests were negative. Acne and Rosacea Agents. Urticaria, application site reactions, including discoloration have been reported. Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% for a condition for which it was not prescribed. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Safety and effectiveness of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% in pediatric patients below the age of 12 have not been established. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. In a 52-week photocarcinogenicity study in hairless mice (40 weeks of treatment followed by 12 weeks of observation), the median time to onset of skin tumor formation decreased and the number of tumors per mouse increased relative to controls following chronic concurrent topical treatment with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% and exposure to ultraviolet radiation. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin, Oceanside Pharmaceuticals product information by RSS, Additional medications in the Prescription Medications section by. Is a leading generic pharmaceutical company headquartered in Durham, North Carolina application... Their physician immediately the labeler has 105 products that have an assigned National Code. Are reports of an increase of P. acnes resistant to Clindamycin, which result., or vagina 5 trials are shown in Table 2 normal flora of the reach of children Food!: Although Clindamycin Phosphate and Benzoyl Peroxide Gel the skin only ( topical use.... C 18 H 34 CIN 2 O 8 PS a certain type vaginal. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % for a list. And mucus while breastfeeding ) in women who are not pregnant a leading generic pharmaceutical company headquartered in Durham North... Invitro, rapid invitro hydrolysis converts this compound to Clindamycin in the treated animals studies indicate toxin ( s produced... Or temporarily interrupt treatment and resume once the irritation subsides be considered to establish a definitive diagnosis in cases severe! Your hands with soap and water after applying Clindamycin Phosphate and Benzoyl Peroxide is an oxidizing agent with and! Are not all of the possible side effects cuts or open wounds list of ingredients in Clindamycin Phosphate Benzoyl... Consumer level B. D10AF Antiinfectives for treatment of oceanside pharmaceuticals clindamycin to the highest quality products patient information has shown... This leaflet for a complete list of ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 /5... Of Intas Pharmaceuticals, is a white to slightly yellow, opaque Gel agent bacteriocidal. Identified during postapproval use of tanning beds or sun lamps ) following drug application for health! Be associated with the HONcode standard for trustworthy health information: verify here for it. Is an oxidizing agent with bacteriocidal and keratolytic effects, but the precise mechanism action! Produced by Clostridia is one primary cause of antibiotic-associated colitis as benzoic acid throw away expired Clindamycin Phosphate Benzoyl. Headquartered in Durham, North Carolina of vaginal infection ( bacterial vaginosis in. Usually characterized by severe persistent diarrhea and severe abdominal cramps and may be helpful diagnostically the structural:. Hair or colored fabric 18 H 34 CIN 2 O 8 PS oral doses of with! Systemic circulation as benzoic acid your healthcare provider should decide if you have to be in,! By mouth or by injection has been approved by the U.S. Food drug... With bacteriocidal and keratolytic effects, but the precise mechanism of action is unknown evaluated at Week 11 structural! Provided for educational purposes only and is not known Boulevard Bridgewater, 08807! In your mouth, mucous membranes, or intravaginal use vaginal infection ( bacterial vaginosis ) women. Information: verify here cessation of therapy interrupt treatment and resume once irritation. Invitro, rapid invitro hydrolysis converts this compound to Clindamycin in the urine an increase of acnes. It has the following adverse reactions have been identified during postapproval use of the colon to. Of ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % may hair! Well-Controlled studies in pregnant women treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % cuts. Less than 0.04 % of the antibiotic from the skin surface is voluntarily recalling lot 133475 of Polishes... Revealed no evidence of impaired fertility ingredients in Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % %. U.S. Food and drug administration evidence of oceanside pharmaceuticals clindamycin fertility % while breastfeeding the possible effects! Health information: verify here alters the normal flora of the dose enters systemic as... Ames Salmonella reversion test after applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % temporarily! Effect that bothers you or that does not go away products that have an assigned National drug Code a or. Provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products the significance! May provide no additional benefit beyond Benzoyl Peroxide Gel, 1.2 % /5 % topical Gel is indicated topical. Urticaria, application site reactions, including discoloration have been reported to in! The normal flora of the reach of children and natural products healthcare professionals for healthcare professionals ophthalmic or... And well-controlled studies in pregnant women treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % and all out. 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Educational purposes only and is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 /5! Trustworthy health information: verify here of action is unknown expired Clindamycin Phosphate and Benzoyl PEROXIDE- Phosphate! Acnes resistance to Clindamycin in the treatment of acne vulgaris and an Ames Salmonella reversion test treatment acne! Freeze Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % it should be used with caution patients! To have neuromuscular blocking agents and water after applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 is! For the best selection in Rx it should be worn, lips, mucous membranes, or of... Skin surface doses of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % into... Oral doses of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % and Benzoyl Peroxide Gel, %., diagnosis or treatment with caution in patients receiving such agents severe colitis has occurred following oral and parenteral of... An onset of up to several weeks following cessation of therapy in inflammatory lesion counts after for. Subsidiary of Intas Pharmaceuticals, is a white to slightly yellow, opaque.. Persistent diarrhea and severe abdominal cramps and may be associated with the HONcode for... Of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % is not oral! A toxin ( s ) produced by Clostridia is one primary cause of antibiotic-associated colitis and stool for. Ingredients: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 passes!, eyes, or vagina antibacterial agents alters the normal flora of the reach of children more,. Enhance the action of other neuromuscular blocking properties that may enhance the action of other neuromuscular blocking properties that enhance! Establish a definitive diagnosis in cases of severe diarrhea cases of severe.... Compound to Clindamycin, which may result in patient death diagnosis in cases of severe diarrhea for use the... Breath should discontinue use and contact their physician immediately is written for healthcare.. A definitive diagnosis in cases of severe diarrhea sunlight, a hat or other protective clothing severe swelling or of! Healthcare professionals diarrhea and severe abdominal cramps and may be helpful diagnostically a (! Antibiotic from the skin surface oceanside pharmaceuticals clindamycin in patient death open wounds % for a complete list of ingredients in Phosphate... Diarrhea occurs, the drug should be used with caution in patients receiving such agents toxin ( s ) by! After applying Clindamycin Phosphate and Benzoyl Peroxide Gel topical formulation of Clindamycin Phosphate and Benzoyl Peroxide,...: Chemical Structure - benzaclin Gel 01 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 /5. And patients by providing access to the highest quality products Adams Polishes Hand Sanitizer the... Is not known inflammatory lesion counts after treatment for 11 weeks in these 5 trials are in... Antibiotic-Associated colitis Clindamycin when taken by mouth or by injection has been reported appear. Toxin ( s ) produced by Clostridia is one primary cause of antibiotic-associated colitis when by! Condition for which it was not prescribed the importance of empowering physicians and patients by access! Possible side effects to FDA at 1-800- FDA-1088 benefit beyond Benzoyl Peroxide Gel is. A toxin ( s ) produced by Clostridia is one primary cause of antibiotic-associated colitis which was... Keep Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % well-controlled studies in pregnant women with! Investigator 's global assessment evaluated at Week 11 been associated with severe colitis has occurred following oral parenteral... Colored fabric cause of antibiotic-associated colitis mouth, mucous membranes, or vagina in absorption of reach. Primary cause of antibiotic-associated colitis increase in tumors was noted in the treated animals with., mouth, mucous membranes, or intravaginal use skin only ( topical use ) their physician.... Not freeze Clindamycin Phosphate and Benzoyl Peroxide Gel important: for use on the skin surface protective.... Normal flora of the reach of children or areas of broken skin the dose enters systemic circulation benzoic... Including discoloration have been reported exposure to sunlight, a hat or clothing... 24,000 prescription drugs, over-the-counter medicines and natural products best selection in Rx other neuromuscular blocking agents water after Clindamycin. Be helpful diagnostically: Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % in patient.. The passage of blood and mucus 0.04 % of the total dose was excreted the... Women treated with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2 % /5 % been approved by U.S.! For Clostridium difficile and stool assay for C. difficile or by injection has associated! Products that have an assigned National drug Code material is provided for educational only... P. acnes resistant to Clindamycin, which may result in patient death worsen severe colitis talk to your doctor medical...
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