Drug Catalog - Product Detail
FLUOCINOLONE ACETONIDE TOPICAL OIL (SCALP OIL) OIL 0.0001 118ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 13925-0507-04 | SETON PHARMACEUTICALS | 118 | 0.01% | OIL |
PACKAGE FILES
Generic Name
FLUOCINOLONE ACETONIDE
Substance Name
FLUOCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
NDA019452
Description
DESCRIPTION Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) 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. Chemically, fluocinolone acetonide is C 24 H 30 F 2 O 6 . It has the following structural formula: Fluocinolone acetonide 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 0.01% Topical Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF and fragrances. 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 0.01% Topical Oil (Scalp Oil) is supplied in bottles containing 4 fluid ounces. It is labeled as Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil) ( NDC # 13925-507-04 ). Fluocinolone Acetonide 0.01% Topical Oil (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 MANUFACTURED BY: Hill Dermaceuticals, Inc. Sanford, Florida 32773 FOR: Seton Pharmaceuticals Manasquan, NJ 08736 1-800-510-3401 Code: 171G244-1 Date: 01/2014
Indications & Usage
INDICATION AND USAGE 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).
Dosage and Administration
DOSAGE AND ADMINISTRATION Fluocinolone Acetonide 0.01% Topical Oil for scalp psoriasis in adults (Scalp Oil): For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Fluocinolone Acetonide 0.01% Topical Oil 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.