Drug Catalog - Product Detail
FLUOCINOLONE ACETONIDE OIL 0.01% (SCALP OIL) 118ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0485-26 | PADAGIS | 118 | 0.01% | OIL |
PACKAGE FILES
Generic Name
FLUOCINOLONE ACETONIDE
Substance Name
FLUOCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA202848
Description
DESCRIPTION Fluocinolone Acetonide Topical Oil, 0.01% contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11, 21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as Fluocinolone Acetonide Oil, 0.01% (Ear Drops) for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide in Fluocinolone Acetonide Topical Oil, 0.01% has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of Fluocinolone Acetonide Topical Oil, 0.01% contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic. Chemical Structure
How Supplied
HOW SUPPLIED Fluocinolone Acetonide Topical Oil, 0.01% is supplied in bottles containing 4 fluid ounces. It is labeled as Scalp Oil (NDC 45802- 485 -26). Scalp Oil is supplied with 2 shower caps. Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. CAUTION: Rx only
Indications & Usage
INDICATION AND USAGE Fluocinolone Acetonide Topical Oil, 0.01% is a low to medium potency corticosteroid indicated: In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).
Dosage and Administration
DOSAGE AND ADMINISTRATION Fluocinolone Acetonide Topical Oil, 0.01% for scalp psoriasis in adults: For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Fluocinolone Acetonide Topical Oil, 0.01% on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.