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

zydus lifesciences limited - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - 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 and benzoyl peroxide gel 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. clindamycin phosphate and benzoyl peroxide gel 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. [see adverse reactions (6.2).] clindamycin phosphate and benzoyl peroxide gel 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)]. pregnanc

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

taro pharmaceuticals u.s.a., inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin phosphate and benzoyl peroxide gel, 1.2%/3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. clindamycin phosphate and benzoyl peroxide gel 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 [see postmarketing experience (6.2)] . clindamycin phosphate and benzoyl peroxide gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see warnings and precautions (5.1)] . risk summary there are no available data on clindamycin phosphate and benzoyl peroxide gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. the limited published data on use

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

mylan pharmaceuticals inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate and benzoyl peroxide gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin phosphate 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 States - English - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate and benzoyl peroxide gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin phosphate 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 States - English - NLM (National Library of Medicine)

bryant ranch prepack - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - 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 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. 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).] 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%. 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 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 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.

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

glaxosmithkline australia pty ltd - benzoyl peroxide, quantity: 50 mg/g; clindamycin phosphate, quantity: 11.9 mg/g (equivalent: clindamycin, qty 10 mg/g) - gel - excipient ingredients: silicon dioxide; purified water; glycerol; sodium hydroxide; disodium lauril sulfosuccinate; dimeticone 100; carbomer 980; poloxamer; disodium edetate - for the topical treatment of comedo, papules and pustular acne vulgaris.

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

mylan pharmaceuticals inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin 5 mg in 1 g - clindamycin phosphate and benzoyl peroxide gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin phosphate 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 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)

mylan pharmaceuticals inc. - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate and benzoyl peroxide gel, 1%/5% is indicated for the topical treatment of acne vulgaris. clindamycin phosphate 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.

Canada - English - Health Canada

taro pharmaceuticals inc - clindamycin (clindamycin phosphate); benzoyl peroxide - gel - 1%; 5% - clindamycin (clindamycin phosphate) 1%; benzoyl peroxide 5% - antibiotics