Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 gram tubes NDC 16714-267-01 80 gram tubes NDC 16714-267-02 454 g jar NDC 16714-267-03 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 16714-276-01 80 gram tubes NDC 16714-276-02 454 g jar NDC 16714-276-03 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 gram tubes NDC 16714-268-01 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]. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Manufactured by: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh-174101, INDIA To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Revised: April 2025; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC: 16714-267-01 15 gms tube Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-01 15 gms carton Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-02 80 gms tube Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-02 80 gms carton Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-03 454 gms jar Triamcinolone Acetonide Ointment USP, 0.5% Rx only NDC: 16714-268-01 15 gms tube Triamcinolone Acetonide Ointment USP, 0.5% Rx only NDC: 16714-268-01 15 gms carton Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-01 15 gms carton Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-01 15 gms tube Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-02 80 gms carton Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-02 80 gms tube Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-03 454 gm jar 505 525 505 505 525 505 525 505 505 505 505 505
- HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 gram tubes NDC 16714-267-01 80 gram tubes NDC 16714-267-02 454 g jar NDC 16714-267-03 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 16714-276-01 80 gram tubes NDC 16714-276-02 454 g jar NDC 16714-276-03 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 gram tubes NDC 16714-268-01 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]. Manufactured for: Northstar Rx LLC. Memphis, TN 38141. Manufactured by: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh-174101, INDIA To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Revised: April 2025
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC: 16714-267-01 15 gms tube Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-01 15 gms carton Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-02 80 gms tube Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-02 80 gms carton Triamcinolone Acetonide Ointment USP, 0.025% Rx only NDC:16714-267-03 454 gms jar Triamcinolone Acetonide Ointment USP, 0.5% Rx only NDC: 16714-268-01 15 gms tube Triamcinolone Acetonide Ointment USP, 0.5% Rx only NDC: 16714-268-01 15 gms carton Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-01 15 gms carton Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-01 15 gms tube Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-02 80 gms carton Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-02 80 gms tube Triamcinolone Acetonide Ointment USP, 0.1% Rx only NDC: 16714-276-03 454 gm jar 505 525 505 505 525 505 525 505 505 505 505 505
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. The structural formula is: Each gram of Triamcinolone Acetonide Ointment USP, 0.025% ,0.1%, 0.5% contains 0.25 mg, 1 mg, 5 mg triamcinolone acetonide, respectively, 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 of Triamcinolone Acetonide Ointment 0.025% to the affected area two to four times daily. Apply a thin film of the 0.1% or the 0.5% Triamcinolone Acetonide Ointment, as appropriate, 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.
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