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

cosette pharmaceuticals, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.1 mg in 1 ml - fluocinolone acetonide topical solution, usp 0.01% 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. pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced hypothalamic-pituitary-adrenal (hpa) axis suppression and cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio. hypothalamic-pituitary-adrenal (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 absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. adm

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

seton pharmaceuticals - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 1 ml - fluocinolone acetonide 0.01% oil ear drops 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). pediatric use: fluocinolone acetonide 0.01% oil ear drops may be used twice daily for up to 2 weeks in pediatric patients 2 years of age and older with chronic eczematous external otitis. fluocinolone acetonide 0.01% oil ear drops is not recommended for use on the face (see adverse reaction section). because of a higher ratio of skin surface area to body mass, children are at a greater risk than adults of hpa-axis-suppression when they are treated with topical corticosteroids. they are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of cushing's syndrome while on treatment. adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children. (see precautions). hpa axis suppression, cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to acth stimulation. manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. fluocinolone acetonide 0.01% oil ear drops is formulated with 48% refined peanut oil nf. peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million. physicians should use caution in prescribing fluocinolone acetonide 0.01% oil ear drops for peanut-sensitive individuals.

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

taro pharmaceuticals u.s.a., inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 118.28 ml - fluocinolone acetonide topical oil is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide 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 topical oil needed to cover the affected areas. as with other corticosteroids, fluocinolone acetonide topical oil should be discontinued when control of disease is achieved. contact the physician if no improvement is seen within 2 weeks. fluocinolone acetonide topical oil should not be applied to the diaper area; diapers or plastic pants may constitute occlusive use. fluocinolone acetonide 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 adver

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

amneal pharmaceuticals llc - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 118.28 ml - 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)

avkare, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 118.28 ml - 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)

seton pharmaceuticals - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 1 ml - fluocinolone acetonide 0.01% topical oil (body oil) is indicated for the topical treatment of atopic dermatitis in adult patients. fluocinolone acetonide 0.01% topical oil (body 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

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

padagis israel pharmaceuticals ltd - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.01 mg in 100 ml - 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).

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

versapharm inc. - an akorn company - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 1 ml - fluocinolone acetonide oil, 0.01% ear drops 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)

padagis israel pharmaceuticals ltd - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.11 mg in 1 ml - fluocinolone acetonide oil, 0.01% ear drops 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)

teligent pharma, inc. - fluocinolone acetonide (unii: 0cd5fd6s2m) (fluocinolone acetonide - unii:0cd5fd6s2m) - fluocinolone acetonide 0.1 mg in 1 g - fluocinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses. topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.