Active ingredients: clindamycin phosphate 1.2% and benzoyl peroxide 5%. 6112 Lincomycins. 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. Sunscreen may also be used. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin. CLINDAMYCIN PHOSPHATE- clindamycin phosphate gelOceanside Pharmaceuticals. All subjects were graded for facial local skin reactions (erythema, peeling, burning, and dryness) on the following scale: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Encube Ethicals , Inc. Important: For use on the skin only (topical use). It may harm them. Active ingredients: clindamycin phosphate 1.2% and benzoyl peroxide 5%. Clindamycin is an antibiotic which works by stopping the growth of bacteria. More Info Fluorouracil Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. Use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% exactly as your healthcare provider tells you to use it. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% for a condition for which it was not prescribed. Active Ingredients: clindamycin phosphate and benzoyl peroxide, Inactive Ingredients: carbomer 980, potassium hydroxide, propylene glycol, and purified water, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies Inc., Laval, Quebec H7L 4A8, Canada. Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. 263 Suppurative dermatosis agents. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. Mean Percent Reduction in Inflammatory Lesion Counts. 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. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during postapproval use of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. 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. If you have to be in sunlight, wear a wide-brimmed hat or other protective clothing. The skin should be gently washed, rinsed with warm water, and patted dry before applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. It may harm them. D01073 Clindamycin phosphate (JP18/USP) 6 Agents against pathologic organisms and parasites. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Safely throw away expired Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. D10AF51 Clindamycin, combinations. If irritancy or dermatitis occurs, reduce frequency of application or temporarily interrupt treatment and resume once the irritation subsides. 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. WARNING. 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, Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. OVERDOSAGE Oral: Reduced rate of absorption with food. Apply a thin layer of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% to the face once daily, in the evening or as directed by the physician. The following adverse reaction is described in more detail in the Warnings and Precautions section of the label: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Stool cultures for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. The clinical significance of this is unknown. 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% Adams Polishes is recalling 19 other lots in, Fri, 04 Nov 2022. 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. Endoscopic examination may reveal pseudomembranous colitis. Clindamycin inhibits bacteria protein synthesis at the ribosomal level by binding to the 50S ribosomal subunit and affecting the process of peptide chain initiation. You may report side effects to FDA at 1-800- FDA-1088. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is a white to slightly yellow, opaque gel. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% applied once daily for 11 weeks was significantly more effective than vehicle, benzoyl peroxide, and clindamycin in the treatment of inflammatory lesions of moderate to moderately severe facial acne vulgaris in three of the five trials (Trials 1, 2, and 5). 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. No significant increase in tumors was noted in the treated animals. Durham, NC 27713 USA, PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT, Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. All Rights Reserved. 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. Do not freeze. Genotoxicity studies were not conducted with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Following multiple applications of Clindamycin Phosphate Topical Gel less than 0.04% of the total dose was excreted in the urine. Severe colitis has occurred following oral and parenteral administration of clindamycin with an onset of up to several weeks following cessation of therapy. Privacy Policy | Copyright 2022. This Patient Information has been approved by the U.S. Food and Drug Administration. are pregnant or plan to become pregnant.It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% will harm your unborn baby. There may be new information. Privacy Policy | Copyright 2022. 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. 2 DOSAGE AND ADMINISTRATION All Rights Reserved. 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. Thornton, Colorado, Adams Polishes, LLC is voluntarily recalling lot 133475 of Adams Polishes Hand Sanitizer to the consumer level. Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen severe colitis. You may report side effects to FDA at 1-800-FDA-1088. 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. Sunscreen may also be used. Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. Available for Android and iOS devices. Systemic absorption of clindamycin has been demonstrated following topical use of clindamycin. FOR EXTERNAL USE ONLY, doxycycline, clindamycin topical, erythromycin topical, tetracycline, Tazorac. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Encube Ethicals Pvt. Dispense Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% with a 60 day expiration date. 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. This Patient Information has been approved by the U.S. Food and Drug Administration. Less than 2% of the dose enters systemic circulation as benzoic acid. Limit your time in sunlight. Stop using Clindamycin Phosphate and Benzoyl Peroxide Gel and call your doctor if you have a skin rash or your skin becomes very red, itchy or swollen. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel is safe and effective in children under 12 years of age. 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. Clindamycin phosphate is C 18H 34ClN 2O 8PS. Clindamycin Phosphate List of the 142 NDC products with the active ingredient Clindamycin Phosphate. 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. 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. Privacy Policy | Copyright 2022. Clindamycin is a lincosamide antibacterial [see Clinical Pharmacology ( 12.4)]. All Rights Reserved. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel is safe and effective for use longer than 12 weeks. Shop Henry Schein Medical for the best selection in Rx. 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. The structural formula for clindamycin phosphate is represented below: Clindamycin phosphate has a molecular weight of 504.97 and its chemical name is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl- trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo--D- galacto-octopyranoside 2-(dihydrogen phosphate). 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. Chlordiazepoxide Hydrochloride and Clidinium Bromide. Excessive or prolonged exposure to sunlight should be limited. More Info Urolet Mb More Info Prednicarbate More Info Metronidazole Gel More Info Erythromycin And Benzoy. It is not known if Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% passes into your breast milk. Local Skin Reactions with Use of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, Combined Results from Five Trials (n = 397). Wash your hands with soap and water after applying Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Package insert / prescribing information 100 mL. Through its subsidiaries, Intas markets its products in 80 countries. These medications may be counterfeit and potentially unsafe. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. The structural formula for clindamycin is represented below: Chemical Structure - benzaclin gel 01 Oceanside Pharmaceuticals product information by RSS, Clindamycin Phosphate and Benzoyl Peroxide, Additional medications in the Prescription Medications section by. We comply with the HONcode standard for trustworthy health information. D10602 Clindamycin phosphate and benzoyl . Avoid the eyes, mouth, mucous membranes, or areas of broken skin. A 1% clindamycin phosphate gel similar to Clindamycin Phosphate Topical Gel caused a statistically significant shortening of the median time to tumor onset in a study in hairless mice in which tumors were induced by exposure to simulated sunlight. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Mean Percent Reduction in Inflammatory Lesion Counts. 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. 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. What are the possible side effects with Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? Dosage form: gel Company Labeler Name: Oceanside Pharmaceuticals Oceanside Pharmaceuticals labeler's code is 68682. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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. 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%). 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. 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. In vitro studies have shown antagonism between erythromycin and clindamycin. Data sources include IBM Watson Micromedex (updated 1 Nov 2022), Cerner Multum (updated 25 Oct 2022), ASHP (updated 12 Oct 2022) and others. General information about Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%. Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. Apply a pea-sized amount of Clindamycin Phosphate and Benzoyl Peroxide Gel to the face once daily. A plan by Ionis Pharmaceuticals to open a development and manufacturing center with 200 new, permanent full-time jobs in Oceanside's El Corazon Park could clear another hurdle this week. 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. 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. Reproduction studies in rats using oral doses of clindamycin hydrochloride and clindamycin palmitate hydrochloride have revealed no evidence of impaired fertility. 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. List of authorized generic versions: Clindamycin Phosphate and Benzoyl Peroxide TOPICAL GEL 25; 10 mg/g; mg/g Oceanside Pharmaceuticals NDC Code: 686820132 Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Onexton. Severe colitis may result in death. No microbiology studies were conducted in the clinical trials with this product. How should I use Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%? However, topical treatment with another formulation containing 1% clindamycin and 5% benzoyl peroxide at doses of 100, 500, or 2,000 mg per kg per day caused a dose-dependent increase in the incidence of keratoacanthoma at the treated skin site of male rats in a 2-year dermal carcinogenicity study in rats. Minimize sun exposure (including use of tanning beds or sun lamps) following drug application. In view of the potential for diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS, and ADVERSE REACTIONS). 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)]. Drug class: Topical acne agents. The clinical significance of this in vitro antagonism is not known. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . Accord Healthcare, Inc., the US subsidiary of Intas Pharmaceuticals, is a leading generic pharmaceutical company headquartered in Durham, North Carolina. This action was taken voluntarily with the. Benzoyl peroxide, a component of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, may cause increased sensitivity to sunlight. Keep Clindamycin Phosphate and Benzoyl Peroxide Gel and all medicines out of the reach of children. 61 Antibiotics. Oceanside Pharmaceuticals 1 April 2020 Clindamycin Phosphate and Benzoyl Peroxide Clindamycin Phosphate and Benzoyl Peroxide Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Medically reviewed by Drugs.com. The expiration date of Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is 60 days from the date when you fill your prescription. 400 Somerset Corp Boulevard Bridgewater, NJ 08807 (908) 927-1400. Benzoyl peroxide is C 14H 14O 4. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% should be used with caution in patients receiving such agents. data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAKAAAAB4CAYAAAB1ovlvAAADOUlEQVR4Xu3XQUpjYRCF0V9RcOIW3I8bEHSgBtyJ28kmsh5x4iQEB6/BWQ . Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. Do not use Clindamycin Phosphate and Benzoyl Peroxide Gel for a condition for which it was not prescribed. Especially tell your healthcare provider if you take a medicine that contains erythromycin. 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. Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5% is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. 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%.
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