Malta - English - Medicines Authority

glaxo smithkline uk limited - benzoyl peroxide; clindamycin - gel - benzoyl peroxide 50 mg/g; clindamycin 10 mg/g - anti-acne preparations

United States - English - NLM (National Library of Medicine)

medimetriks pharmaceuticals - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin 10 mg in 1 g - neuac® (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. neuac® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. neuac® (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. anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% [see adverse reactions (6.2) ]. neuac® (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

United States - English - NLM (National Library of Medicine)

medimetriks pharmaceuticals - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin 10 mg in 1 g - neuac® (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. neuac® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. neuac® (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. anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% [see adverse reactions (6.2) ]. neuac® (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) ]. pregnancy category c. there are no adequate and well-controlled studies in pregnant women treated with clindamycin phosphate and benzoyl peroxide gel, 1.2%/5%. neuac® (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. developmental toxicity studies performed in rats and mice using oral doses of clindamycin up to 600 mg per kg per day (240 and 120 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2 , respectively) or subcutaneous doses of clindamycin up to 250 mg per kg per day (100 and 50 times the amount of clindamycin in the highest recommended adult human dose based on mg per m2 , respectively) revealed no evidence of teratogenicity. it is not known whether neuac® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/5% is excreted into human milk after topical application. however, orally and parenterally administered clindamycin has been reported to appear in breast milk. 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. because many drugs are excreted in human milk, caution should be exercised when neuac® (clindamycin phosphate and benzoyl peroxide) gel, 1.2%/5% is administered to a nursing woman. 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. clinical studies of clindamycin phosphate and benzoyl peroxide gel, 1.2%/5% did not include sufficient numbers of subjects ages 65 and over to determine whether they respond differently from younger subjects.

United States - English - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin and benzoyl peroxide topical gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. it is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

United States - English - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin and benzoyl peroxide topical gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin and benzoyl peroxide topical gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. it is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin and benzoyl peroxide gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin and benzoyl peroxide gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. it is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

3% and 1%) (stiefel laboratories (uk) ltd - clindamycin phosphate; benzoyl peroxide - cutaneous gel - 10mg/1gram ; 30mg/1gram

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - tretinoin, quantity: 0.25 mg; clindamycin phosphate, quantity: 12 mg (equivalent: clindamycin, qty 10 mg) - gel - excipient ingredients: purified water; disodium edetate; methyl hydroxybenzoate; carbomer 981; butylated hydroxytoluene; polysorbate 80; citric acid; glycerol; propyl hydroxybenzoate; trometamol - acnatac is indicated for the topical treatment of acne vulgaris when comedones, papules and pustules are present in patients 12 years or older. consideration should be given to official guidance on the appropriate use of antibacterial agents and acne treatment.

United States - English - NLM (National Library of Medicine)

sincerus florida, llc - benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4), clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) -

United States - English - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - clindamycin (unii: 3u02el437c) (clindamycin - unii:3u02el437c) - clindamycin and benzoyl peroxide gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin and benzoyl peroxide gel, 1%/5% is contraindicated in those individuals who have shown hypersensitivity to any of its components or to lincomycin. it is also contraindicated in those having a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis.