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

e. fougera & co. a division of fougera pharmaceuticals inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.25 mg in 1 g - topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Philippines - English - FDA (Food And Drug Administration)

neomycin sulfate , polymyxin b sulfate , fluocinolone acetonide - otic solution - 3.5 mg/10,000 units/250 mcg per ml

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

lyne laboratories, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 1 ml

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

physicians total care, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.01% topical oil is a low to medium potency corticosteroid indicated: in adult patients for the treatment of psoriasis of the scalp (scalp oil). fluocinolone acetonide 0.01% topical oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions section).

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

amneal pharmaceuticals llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.01% topical oil is indicated for the topical treatment of atopic dermatitis in adult patients.   fluocinolone acetonide 0.01% topical oil is indicated for the topical treatment of moderate to severe atopic dermatitis in pediatric patients, 3 months and older for up to 4 weeks. safety and effectiveness in pediatric patients younger than 3 months of age have not been established.   apply the least amount of fluocinolone acetonide 0.01% topical oil needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide 0.01% topical oil should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide 0.01% topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide 0.01% topical oil should not be used on the face, axillae, or groin unless directed by the physician.  application to intertriginous areas should be avoided due to the increased risk of local adverse reactions [see adverse reactions (6) and use in specific populations (8.4)] . none pregnancy category c: corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. there are no adequate and well-controlled studies in pregnant women on teratogenic effects from fluocinolone acetonide 0.01% topical oil. therefore, fluocinolone acetonide 0.01% topical oil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. it is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. because many drugs are excreted in human milk, caution should be exercised when fluocinolone acetonide 0.01% topical oil is administered to a nursing woman. systemic adverse reactions in pediatric patients hpa axis suppression, cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and subnormal response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. because of a higher ratio of skin surface area to body mass, children are at a greater risk for systemic adverse reactions than are adults when treated with topical corticosteroids [see warnings and precautions (5.1)] . evaluation in peanut-sensitive pediatric subjects a clinical study was conducted to assess the safety of fluocinolone acetonide 0.01% topical oil, which contains refined peanut oil, on subjects with known peanut allergies. the study enrolled 13 subjects with atopic dermatitis, 6 to 17 years of age. of the 13 subjects, 9 were radioallergosorbent test (rast) positive to peanuts and 4 had no peanut sensitivity (controls). the study evaluated the subjects’ responses to both prick test and patch test utilizing peanut oil nf, fluocinolone acetonide 0.01% topical oil and histamine/saline controls. subjects were also treated with fluocinolone acetonide topical oil 0.01% twice daily for 7 days. prick test and patch test results for all 13 patients were negative to fluocinolone acetonide 0.01% topical oil and the refined peanut oil. one of the 9 peanut-sensitive patients experienced an exacerbation of atopic dermatitis after 5 days of fluocinolone acetonide 0.01% topical oil. the bulk peanut oil nf, used in fluocinolone acetonide 0.01% topical oil is heated at 475°f for at least 15 minutes, which should provide for adequate decomposition of allergenic proteins [see description (11)] . evaluation in pediatric subjects 2 to 6 years old open-label safety studies were conducted on 33 children (20 subjects ages 2 to 6 years, 13 subjects ages 7 to 12 years) with moderate to severe stable atopic dermatitis. subjects were treated with fluocinolone acetonide 0.01% topical oil twice daily for 4 weeks. baseline body surface area involvement was 50% to 75% in 15 subjects and greater than 75% in 18 subjects. morning pre-stimulation cortisol and post-acth stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. at the end of treatment, 4 out of 18 subjects aged 2 to 5 years showed low pre-stimulation cortisol levels (3.2 to 6.6 mcg/dl; normal: cortisol > 7 mcg/dl) but all had normal responses to 0.25 mg of acth stimulation (cortisol > 18 mcg/dl). evaluation in pediatric subjects 3 months to 2 years old an open-label safety study was conducted in 29 children (7 subjects ages 3 to 6 months, 7 subjects ages > 6 to 12 months and 15 subjects ages > 12 months to 2 years of age) to assess the hpa axis by acth stimulation testing following use of fluocinolone acetonide 0.01% topical oil twice daily for 4 weeks. all subjects had moderate to severe atopic dermatitis with disease involvement on at least 20% body surface area. baseline body surface area involvement was 50% to 75% in 11 subjects and greater than 75% in 7 subjects. morning pre-stimulation and post-acth stimulation cortisol levels were obtained in each subject at the beginning of the trial and at the end of 4 weeks of treatment. all subjects had normal responses to 0.125 mg of acth stimulation (cortisol > 18 mcg/dl).

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

amneal pharmaceuticals llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide oil 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years old and older. fluocinolone acetonide oil 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions).

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

taro pharmaceuticals u.s.a., inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical oil is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions section).

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

cosette pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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

taro pharmaceuticals u.s.a., inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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

rising pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide topical oil, 0.01% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. this product contains refined peanut oil nf (see precautions section). pediatric use: fluocinolone acetonide topical oil, 0.01% may be used twice daily for up to 4 weeks in pediatric patients 2 years and older with moderate to severe atopic dermatitis.  fluocinolone acetonide topical oil, 0.01% should not be applied to the diaper area. application to intertriginous areas should be avoided due to the increased possibility of local adverse events such as striae, atrophy, and telangiectasia, which may be irreversible. the smallest amount of drug needed to cover the affected areas should be applied. long term safety in the pediatric population has not been established. fluocinolone acetonide topical oil, 0.01% is not recommended for use on the face (see adverse reactions section). because of a higher ratio of skin surface area to body mass, children are at