Singapore - Engels - HSA (Health Sciences Authority)

glaxosmithkline pte ltd - benzoyl peroxide hydrous; clindamycin phosphate - gel - 6.67% w/w - benzoyl peroxide hydrous 6.67% w/w; clindamycin phosphate 1.28% w/w

Australië - Engels - Department of Health (Therapeutic Goods Administration)

neo health (otc) pty ltd - benzoyl peroxide, quantity: 100 mg/g - cream - excipient ingredients: sodium lauryl sulfate; sodium citrate dihydrate; colloidal anhydrous silica; purified water; propyl hydroxybenzoate; cetyl alcohol; citric acid monohydrate; propylene glycol; methyl hydroxybenzoate; glycerol; glyceryl monostearate; peg-100 stearate - for the treatment of acne.

België - Engels - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

galderma benelux b.v. - benzoyl peroxide hydrous 50 mg/ml - cutaneous suspension - 5 % - benzoyl peroxide 50 mg/ml - benzoyl peroxide

Verenigde Staten - Engels - NLM (National Library of Medicine)

bausch health us, llc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin 10 mg in 1 g - acanya® gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. acanya 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 acanya gel [see postmarketing experience (6.2)] . acanya 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 acanya 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 of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of pregnancy-related adverse outcomes (see data) .in limited published cli

Malta - Engels - Medicines Authority

beecham group plc 980 great west road, brentford, middlesex, tw8 9gs, united kingdom - benzoyl peroxide - cream - benzoyl peroxide 4 % (w/w) - anti-acne preparations

Canada - Engels - Health Canada

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

Verenigde Staten - Engels - NLM (National Library of Medicine)

bausch health us, llc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - clindamycin 10 mg in 1 g - onexton® (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. onexton 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 onexton gel [see postmarketing experience (6.2) ]. onexton 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 onexton 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 of clindamycin in pregnant women with exposure during the first trimester are insufficient to inform a drug-associated risk of

Malta - Engels - Medicines Authority

galderma international tour europlaza - 20 avenue andre prothin, la defense 4, 92 927 paris la defense cedex, france - adapalene, benzoyl peroxide - gel - benzoyl peroxide 25 mg/g adapalene 1 mg/g - anti-acne preparations

Verenigde Staten - Engels - NLM (National Library of Medicine)

stiefel laboratories inc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - duac® (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. duac 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. duac 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 duac gel. [see adverse reactions (6.2).] duac 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)]. pregnancy category c. there are no adequate and well-controlled studies in pregnant women treated with duac gel. duac gel should be used during pregnan

Canada - Engels - Health Canada

sandoz canada incorporated - adapalene; benzoyl peroxide - gel - 0.1%; 2.5% - adapalene 0.1%; benzoyl peroxide 2.5% - keratolytic agents