RVP

Drug Catalog - Product Detail

TRIAMCINOLONE ACE CRM USP 0.1% 15GM

NDC Mfr Size Str Form
68462-0131-17 GLENMARK PHARMACEUTICALS 15 0.1% CREAM
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Generic Name
TRIAMCINOLONE ACETONIDE
Substance Name
TRIAMCINOLONE ACETONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA207117
Description
DESCRIPTION The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The steroids in this class include triamcinolone acetonide. Triamcinolone acetonide USP is designated chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. Graphic Formula: C 24 H 31 FO 6 M.W. 434.50 Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg triamcinolone acetonide USP in a cream base consisting of emulsifying wax, cetyl alcohol, isopropyl palmitate, sorbitol solution, glycerine, lactic acid, benzyl alcohol and purified water. Triamcinolone Acetonide Chemical Structure
How Supplied
HOW SUPPLIED Triamcinolone Acetonide Cream USP, 0.1% is available as follows: NDC 68462-131-17 15 g tube (1 tube per carton) NDC 68462-131-35 30 g tube (1 tube per carton) NDC 68462-131-49 80 g tube (1 tube per carton) NDC 68462-131-59 454g jar Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road, District: Solan,Himachal Pradesh - 173205 India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa July 2016
Indications & Usage
INDICATIONS AND USAGE Triamcinolone Acetonide Cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage and Administration
DOSAGE AND ADMINISTRATION Apply Triamcinolone Acetonide Cream USP, 0.1%, as appropriate, to the affected area two to three times daily. Rub in gently. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Gently rub a small amount of cream into the lesion until it disappears. Reapply the preparation leaving a thin coating on the lesion, cover with pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide cream under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional cream should be applied, without occlusion, during the day. Reapplication is essential at each dressing change. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.