Drug Catalog - Product Detail
FLUOCINONIDE CREAM USP CRM 0.001 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68682-0992-30 | OCEANSIDE PHARMACEUTICALS | 30 | 0.1% | CREAM |
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Description
11DESCRIPTION Fluocinonide Cream, 0.1% contains fluocinonide, a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and antipruritic agents. Fluocinonide has the chemical name 6 alpha, 9 alpha-difluoro-11 beta, 21-dihydroxy-16 alpha, 17 alpha-isopropylidenedioxypregna-1, 4-diene-3,20-dione 21-acetate. Its chemical formula is C 26 H 32 F 2 O 7 and it has a molecular weight of 494.58. It has the following chemical structure: Fluocinonide is an almost odorless white to creamy white crystalline powder. It is practically insoluble in water and slightly soluble in ethanol. Each gram of Fluocinonide Cream contains 1 mg micronized fluocinonide in a cream base of anhydrous citric acid USP, carbopol 980 NF, diisopropanolamine, dimethyl isosorbide, glyceryl monostearate NF, glyceryl stearate (and) PEG-100 stearate, propylene glycol USP, and purified water USP. fluocinonide-01.jpg
How Supplied
16HOW SUPPLIED/STORAGE AND HANDLING Fluocinonide Cream, 0.1% is white to off-white in color and is supplied in tubes as follows: 30 g NDC 68682-992-30 60 g NDC 68682-992-60 120 g NDC 68682-992-10 Store at controlled room temperature 15° to 30°C (59° to 86°F). Keep the tube tightly closed.
Indications & Usage
1INDICATIONS AND USAGE Fluocinonide Cream is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older. ( 1 ) Limitation of Use: • Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. ( 1 ) • Avoid use on the face, groin, or axillae. ( 1.2 ) • Avoid use in perioral dermatitis or rosacea. ( 1.2 ) 1.1 Indications Fluocinonide Cream, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [ see Use in Specific Populations (8.4) ]. 1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Therapy should be discontinued when control of the disease is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Do not use more than half of the 120 g tube per week. Fluocinonide Cream should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Dosage and Administration
2DOSAGE AND ADMINISTRATION For topical use only. Fluocinonide Cream is not for ophthalmic, oral, or intravaginal use. For psoriasis, apply a thin layer of Fluocinonide Cream once or twice daily to the affected skin areas as directed by a physician. Twice-daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment. For atopic dermatitis, apply a thin layer of Fluocinonide Cream once daily to the affected skin areas as directed by a physician. Once-daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [ see Clinical Studies (14) ] . For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream once or twice daily to the affected areas as directed by a physician. For topical use only. Fluocinonide Cream is not for ophthalmic, oral, or intravaginal use. ( 2 ) Psoriasis: apply a thin layer once or twice daily to the affected skin areas. ( 2 ) Atopic Dermatitis: apply a thin layer once daily to the affected skin areas. ( 2 ) Corticosteroid Responsive Dermatoses, other than psoriasis or atopic dermatitis: apply a thin layer once or twice daily to the affected areas. ( 2 )