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

sandoz inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 20.5 mg in 1 ml

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

preferred pharmaceuticals, inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 20.5 mg in 1 ml

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

sandoz inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf) - adapalene 3 mg in 1 g - adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. adapalene gel, 0.3% should not be administered to individuals who are hypersensitive to adapalene or any of the components in the gel vehicle. teratogenic effects. pregnancy category c. retinoids may cause fetal harm, when administered to pregnant women.  adapalene has been shown to be teratogenic in rats and rabbits when administered orally (see animal data below).  there are no adequate and well-controlled studies in pregnant women.  adapalene gel, 0.3% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  the safety and efficacy of adapalene gel, 0.3% in pregnancy has not been established. human data in clinical trials involving adapalene gel, 0.3% in the treatment of acne vulgaris, women of child-bearing potential initiated treatment only after having had a negative pregnancy test and used effective birth control measures during therapy.  ho

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

a-s medication solutions - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole vaginal gel usp, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). - note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with

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

sandoz inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole 7.5 mg in 1 g - metronidazole vaginal gel usp, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). - note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with

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

amneal pharmaceuticals of new york llc - naftifine hydrochloride (unii: 25ur9n9041) (naftifine - unii:4fb1ton47a) - naftifine hydrochloride cream, 2% is indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism trichophyton rubrum . none. risk summary there are no available data with naftifine hydrochloride cream, 2% in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 18 times the maximum recommended human dose (mrhd) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 2 times the mrhd in pregnant rats or 4 times the mrhd in pregnant rabbits [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defect

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

a-s medication solutions - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by pityrosporum orbiculare (also known as malassezia furfur  or  m. orbiculare ). note: tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. treatment of the infection may not immediately result in normalization of pigment to the affected sites. normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

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

sandoz inc. - adapalene (unii: 1l4806j2qf) (adapalene - unii:1l4806j2qf), benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm) - adapalene and benzoyl peroxide gel 0.1% / 2.5% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none pregnancy category c. there are no well-controlled trials in pregnant women treated with adapalene and benzoyl peroxide gel 0.1% / 2.5%. animal reproduction studies have not been conducted with the combination gel or benzoyl peroxide. furthermore, such studies are not always predictive of human response; therefore, adapalene and benzoyl peroxide gel 0.1% / 2.5% should be used during pregnancy only if the potential benefit justifies the risk to the fetus. no teratogenic effects were observed in rats treated with oral doses of 0.15 to 5.0 mg adapalene/kg/day, up to 25 times (mg/m2 /day) the maximum recommended human dose (mrhd) of 2 grams of adapalene and benzoyl peroxide gel 0.1% / 2.5%. however, teratogenic changes were observed in rats and rabbits when treated with oral doses of ≥ 25 mg adapalene/kg/day representing 123 and 246 times mrhd, respectively. findings in

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

rpk pharmaceuticals, inc. - metronidazole (unii: 140qmo216e) (metronidazole - unii:140qmo216e) - metronidazole vaginal gel usp, 0.75% is indicated in the treatment of bacterial vaginosis (formerly referred to as haemophilus vaginitis, gardnerella vaginitis, nonspecific vaginitis, corynebacterium vaginitis, or anaerobic vaginosis). - note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% koh solution, and (c) contains clue cells on microscopic examination. gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent lactobacillus morphology, (b) predominance of gardnerella morphotype, and (c) absent or few white blood cells. note: for purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a ph of greater than 4.5, (b) emits a “fishy” amine odor when mixed with

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

amneal pharmaceuticals of new york llc - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology ( 12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data) . the background ris