Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Triamcinolone Acetonide Cream USP, 0.025% Triamcinolone Acetonide Cream USP, 0.1% 15 gram tubes NDC 0168-0003-15 15 gram tubes NDC 0168-0004-15 80 gram tubes NDC 0168-0003-80 80 gram tubes NDC 0168-0004-80 1 Lb jars NDC 0168-0004-16 Triamcinolone Acetonide Cream USP, 0.5% 15 gram tubes NDC 0168-0002-15. Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. Fougera PHARMACEUTICALS INC. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville New York 11747 I20215G/IF20215G R09/11 #227 46165001A R06/15 #65; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.025% 15g CONTAINER NDC 0168-0003-15 FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.025% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 005percentlabel.jpg; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.025% 15g CARTON NDC 0168-0003-15 Rx only FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.025% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 0025percentcartonserialized; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.1% 15g CONTAINER NDC 0168-0004-15 FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.1% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams triamcream15gmtube; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.1% 15g CARTON NDC 0168-0004-15 Rx only FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.1% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 01percentcartonserialized; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.5% 15g CONTAINER NDC 0168-0002-15 FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.5% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE . NET WT 15 grams 05percentlabel; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.5% 15g CARTON NDC 0168-0002-15 Rx only FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.5% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 05percentcartonserialized
- HOW SUPPLIED: Triamcinolone Acetonide Cream USP, 0.025% Triamcinolone Acetonide Cream USP, 0.1% 15 gram tubes NDC 0168-0003-15 15 gram tubes NDC 0168-0004-15 80 gram tubes NDC 0168-0003-80 80 gram tubes NDC 0168-0004-80 1 Lb jars NDC 0168-0004-16 Triamcinolone Acetonide Cream USP, 0.5% 15 gram tubes NDC 0168-0002-15. Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. Fougera PHARMACEUTICALS INC. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville New York 11747 I20215G/IF20215G R09/11 #227 46165001A R06/15 #65
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.025% 15g CONTAINER NDC 0168-0003-15 FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.025% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 005percentlabel.jpg
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.025% 15g CARTON NDC 0168-0003-15 Rx only FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.025% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 0025percentcartonserialized
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.1% 15g CONTAINER NDC 0168-0004-15 FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.1% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams triamcream15gmtube
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.1% 15g CARTON NDC 0168-0004-15 Rx only FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.1% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 01percentcartonserialized
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.5% 15g CONTAINER NDC 0168-0002-15 FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.5% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE . NET WT 15 grams 05percentlabel
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 0.5% 15g CARTON NDC 0168-0002-15 Rx only FOUGERA ® TRIAMCINOLONE ACETONIDE CREAM USP, 0.5% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 05percentcartonserialized
Overview
Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C 24 H 31 FO 6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. chemstructure
Indications & Usage
: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
: Apply to the affected area as a thin film as follows: Triamcinolone Acetonide Cream USP, 0.025% two to four times daily; Triamcinolone Acetonide Cream USP, 0.1% and 0.5% two or three times daily 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.
Warnings & Precautions
No warnings available yet.
Contraindications
: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
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