Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 80 gram tubes NDC 0168-0005-80 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 0168-0006-15 80 gram tubes NDC 0168-0006-80 453.6 gram (1lb) jars NDC 0168-0006-16 Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I20515K/IF20515K R05/13 #221 Or 46171939A R10/15 #94; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 80 G CONTAINER (0.025%) NDC 0168-0005-80 FOUGERA ® TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 80 grams label80gram; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 80 G CARTON (0.025%) NDC 0168-0005-80 FOUGERA ® Rx only TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 80 grams carton80gram; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G LABEL (0.1%) NDC 0168-0006-15 FOUGERA ® TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams label15gram; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON (0.1%) NDC 0168-0006-15 FOUGERA ® Rx only TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 15gramcarton
- HOW SUPPLIED: Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 80 gram tubes NDC 0168-0005-80 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 0168-0006-15 80 gram tubes NDC 0168-0006-80 453.6 gram (1lb) jars NDC 0168-0006-16 Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I20515K/IF20515K R05/13 #221 Or 46171939A R10/15 #94
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 80 G CONTAINER (0.025%) NDC 0168-0005-80 FOUGERA ® TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 80 grams label80gram
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 80 G CARTON (0.025%) NDC 0168-0005-80 FOUGERA ® Rx only TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 80 grams carton80gram
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G LABEL (0.1%) NDC 0168-0006-15 FOUGERA ® TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1% Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams label15gram
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON (0.1%) NDC 0168-0006-15 FOUGERA ® Rx only TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1% WARNING: Keep out of reach of children. FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. NET WT 15 grams 15gramcarton
Overview
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment 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 molecular formula C 24 H 31 FO 6 and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. structure
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 Ointment USP, 0.025% two to four times daily; Triamcinolone Acetonide Ointment USP, 0.1% 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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