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

intendis inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g - finacea gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. 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. patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing. finacea gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.

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

alvogen, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g

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

bayer healthcare pharmaceuticals inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g - finacea® (azelaic acid) gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. 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. there are no adequate and well-controlled studies in pregnant women. therefore, finacea gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. e

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

bayer healthcare pharmaceuticals inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid .15 g in 1 g - finacea(azelaic acid) foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. none. there are no adequate and well-controlled studies in pregnant women. therefore, finacea foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% foam. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the maximum recommended human dose (mrhd) based on body surface area (bsa)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the mrhd based on bsa) and cynomolgus monkeys g

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

physicians total care, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g - finacea gel, 15%, is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. 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. patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages and to use only very mild soaps or soapless cleansing lotion for facial cleansing. finacea gel, 15%, is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation.

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

allergan, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.2 g in 1 g - azelex ®  cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris. azelex ®  cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

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

physicians total care, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.2 g in 1 g - azelex® cream is indicated for the topical treatment of mild-to-moderate inflammatory acne vulgaris. azelex® cream is contraindicated in individuals who have shown hypersensitivity to any of its components.

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

sincerus florida, llc - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt), niacinamide (unii: 25x51i8rd4) (niacinamide - unii:25x51i8rd4) -

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

volans epic llc - glycerin (unii: pdc6a3c0ox) (glycerin - unii:pdc6a3c0ox), kaolin (unii: 24h4nwx5co) (kaolin - unii:24h4nwx5co), salicylic acid (unii: o414pz4lpz) (salicylic acid - unii:o414pz4lpz), zinc pidolate (unii: c32pq86dh4) (zinc pidolate - unii:c32pq86dh4), azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - this extraordinary face cleanser can help you battle acne flare-ups. it contains the goodness of salicylic acid, azelaic acid, and glycerin that aids in the reduction of acne while keeping the natural glow of your skin. for treatment of acne-prone skin.

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