Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes: 15 g tube – NDC 21922-063-04 30 g tube – NDC 21922-063-05 80 g tube – NDC 21922-063-15 1 lb (454 g) jar – NDC 21922-063-30 Storage Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature] Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA C100917 Rev. 11/2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label - 15 g NDC 21922- 063 -04 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 15 g Rx only Carton Label - 30 g NDC 21922- 063 -05 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 30 g Rx only Carton Label - 80 g NDC 21922- 063 -15 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 80 g Rx only Jar Label - 1 IB (454g) NDC 21922- 063 -30 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 1 Ib (454g) Rx only Carton 15gm Carton 30gm Carton 80gm Jar 454gm
- HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes: 15 g tube – NDC 21922-063-04 30 g tube – NDC 21922-063-05 80 g tube – NDC 21922-063-15 1 lb (454 g) jar – NDC 21922-063-30 Storage Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature] Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Drive, Suite 202, Durham, NC 27713, USA C100917 Rev. 11/2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label - 15 g NDC 21922- 063 -04 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 15 g Rx only Carton Label - 30 g NDC 21922- 063 -05 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 30 g Rx only Carton Label - 80 g NDC 21922- 063 -15 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 80 g Rx only Jar Label - 1 IB (454g) NDC 21922- 063 -30 Triamcinolone Acetonide Ointment USP, 0.1% For External Use Only Not For Ophthalmic Use Net Wt. 1 Ib (454g) Rx only Carton 15gm Carton 30gm Carton 80gm Jar 454gm
Overview
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 is designated chemically as 9-Fluoro-11β, 16α, 17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. C 24 H 31 FO 6 . M.W.434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1mg triamcinolone acetonide in an ointment base of light mineral oil and white petrolatum. Str.
Indications & Usage
INDICATIONS & USAGE Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Dosage & Administration
DOSAGE & ADMINISTRATION Apply a thin film to the affected area two to three times daily. Occlusive Dressing Technique Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a 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 Ointment 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 ointment 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.
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 preparations.
Adverse Reactions
The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings (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 Encube Ethicals Private Limited, at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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