Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Triamcinolone Acetonide Cream USP 0.025% 15 gram tubes NDC 0713-0226-15 80 gram tubes NDC 0713-0226-80 Triamcinolone Acetonide Cream USP 0.1% 15 gram tubes NDC 0713-0225-15 30 gram tubes NDC 0713-0225-31 80 gram tubes NDC 0713-0225-80; PRINCIPAL DISPLAY PANEL NDC 0713-0225-15 Triamcinolone Acetonide Cream, USP 0.1% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0225-31 Triamcinolone Acetonide Cream, USP 0.1% 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0225-80 Triamcinolone Acetonide Cream, USP 0.1% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0226-15 Triamcinolone Acetonide Cream, USP 0.1% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0226-80 Triamcinolone Acetonide Cream, USP 0.1% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. Triamcinolone Acetonide Cream-2 Triamcinolone Acetonide Cream-3 Triamcinolone Acetonide Cream-4 Triamcinolone Acetonide Cream-5 Triamcinolone Acetonide Cream-6 Triamcinolone Acetonide Cream-7 Triamcinolone Acetonide Cream-8 Triamcinolone Acetonide Cream-9 Triamcinolone Acetonide Cream-10 Triamcinolone Acetonide Cream-11
- HOW SUPPLIED Triamcinolone Acetonide Cream USP 0.025% 15 gram tubes NDC 0713-0226-15 80 gram tubes NDC 0713-0226-80 Triamcinolone Acetonide Cream USP 0.1% 15 gram tubes NDC 0713-0225-15 30 gram tubes NDC 0713-0225-31 80 gram tubes NDC 0713-0225-80
- PRINCIPAL DISPLAY PANEL NDC 0713-0225-15 Triamcinolone Acetonide Cream, USP 0.1% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0225-31 Triamcinolone Acetonide Cream, USP 0.1% 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0225-80 Triamcinolone Acetonide Cream, USP 0.1% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0226-15 Triamcinolone Acetonide Cream, USP 0.1% 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0226-80 Triamcinolone Acetonide Cream, USP 0.1% 80 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. Triamcinolone Acetonide Cream-2 Triamcinolone Acetonide Cream-3 Triamcinolone Acetonide Cream-4 Triamcinolone Acetonide Cream-5 Triamcinolone Acetonide Cream-6 Triamcinolone Acetonide Cream-7 Triamcinolone Acetonide Cream-8 Triamcinolone Acetonide Cream-9 Triamcinolone Acetonide Cream-10 Triamcinolone Acetonide Cream-11
Overview
FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only DESCRIPTION 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 USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream USP 0.1% contains: 1 mg of triamcinolone acetonide USP per gram in a water washable cream base consisting of mineral oil (and) lanolin alcohol, isopropyl palmitate NF, propylene glycol stearate, propylene glycol USP, cetyl alcohol NF, sorbitan monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40) stearate NF, propylparaben NF, methylparaben NF and purified water USP. Triamcinolone Acetonide Cream-1
Indications & Usage
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Apply Triamcinolone Acetonide Cream USP 0.025% to the affected area two to four times daily. Rub in gently. Apply the 0.1% Triamcinolone Acetonide Cream, as appropriate, to the affected area two to three times daily. Rub in gently. 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. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov /medwatch .
Storage & Handling
STORAGE Store at 20-25°C (68-77°F) [ see USP Controlled Room Temperature ]. Keep out of reach of children. Avoid excessive heat. Protect from freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 03/2022 8-TRIACRCPLNC2 VC7611
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