Drug Catalog - Product Detail
TRIAMCINOLONE ACET CREAM USP CRM 0.001 454GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 67877-0251-45 | ASCEND LABORATORIES | 454 | 0.1% | CREAM |
PACKAGE FILES
Generic Name
TRIAMCINOLONE ACETONIDE
Substance Name
TRIAMCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA088042
Description
DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Triamcinolone acetonide is a member of this class. Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its structural formula is: Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg triamcinolone acetonide USP in a cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and potassium sorbate. Structure
How Supplied
HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.025% is supplied in: 15 grams tube NDC 67877-317-15 80 grams tube NDC 67877-317-80 454 grams jar NDC 67877-317-45 Triamcinolone Acetonide Cream USP, 0.1% is supplied in: 15 grams tube NDC 67877-251-15 30 grams tube NDC 67877-251-30 80 grams tube NDC 67877-251-80 454 grams jar NDC 67877-251-45 Triamcinolone Acetonide Cream USP, 0.5% is supplied in: 15 grams tube NDC 67877-318-15 Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Manufactured for: Ascend Laboratories, LLC, Parsippany, NJ 07054 Manufactured by: Crown Laboratories, Inc., Johnson City, TN 37604 P1810.02 Revised: DEC 2016
Indications & Usage
INDICATIONS & USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
DOSAGE & ADMINISTRATION Topical corticosteroids are generally applied to the affected area as a thin film two to four times daily for the 0.025% strength and two or three times daily for the 0.1% and 0.5% strength depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.