Ամերիկայի Միացյալ Նահանգներ - անգլերեն - 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

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - 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.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

sol-gel technologies, inc. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - twyneo is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. twyneo is contraindicated in patients with a history of hypersensitivity reaction to benzoyl peroxide or any components of twyneo [see warnings and precautions (5.1)] . risk summary available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide. there are no data on twyneo use in pregnant women. there are reports of major birth defects reported with maternal use of topical tretinoin similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy (see data ). animal reproductive stu

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

galderma laboratories, l.p. - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - twyneo is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. twyneo is contraindicated in patients with a history of hypersensitivity reaction to benzoyl peroxide or any components of twyneo [see warnings and precautions (5.1)] . risk summary available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.  studies conducted with topical benzoyl peroxide have not demonstrated systemic absorption and maternal use is not expected to result in fetal exposure to benzoyl peroxide.  there are no data on twyneo use in pregnant women. there are reports of major birth defects reported with maternal use of topical tretinoin similar to those seen in infants exposed to oral retinoids, but these case reports do not establish a pattern or association with tretinoin-related embryopathy (see data ). animal reproductive s

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

lexon pharmaceuticals (ireland) limited - benzoyl peroxide - gel - peroxides; benzoyl peroxide

Կանադա - անգլերեն - Health Canada

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

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

galderma (uk) ltd - benzoyl peroxide - gel - 5 %w/w - benzoyl peroxide

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

neo health (otc) pty ltd - benzoyl peroxide, quantity: 50 mg/g - cream - excipient ingredients: purified water; citric acid; propyl hydroxybenzoate; stearic acid; propylene glycol; cetyl alcohol; titanium dioxide; glycerol; colloidal anhydrous silica; sodium citrate dihydrate; methyl hydroxybenzoate; glyceryl monostearate; sodium lauryl sulfate; colour - for the treatment of acne.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

the mentholatum company - benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - benzoyl peroxide – acne treatment - for the treatment of acne. - helps prevent new acne blemishes.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

perrigo new york inc - clindamycin phosphate (unii: eh6d7113i8) (clindamycin - unii:3u02el437c) - clindamycin phosphate 10 mg in 1 g - 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.