Triamcinolone acetonide TRIAMCINOLONE ACETONIDE MACLEODS PHARMACEUTICALS LIMITED FDA Approved 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% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum. str

Drug Facts

Composition & Profile

Strengths
0.025 % 15 g 80 g 454 g 0.1 % 0.5 %
Quantities
15 count
Treats Conditions
Indications Usage Triamcinolone Acetonide Ointment Is Indicated For The Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses
Pill Appearance
Color: white

Identifiers & Packaging

Container Type BOX
UPC
0333342331540 0333342331809 0333342333803
UNII
F446C597KA
Packaging

HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 gram tubes NDC 33342-331-15 80 gram tubes NDC 33342-331-80 454 g jar NDC 33342-331-54 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 33342-333-15 80 gram tubes NDC 33342-333-80 454 g jar NDC 33342-333-54 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 gram tubes NDC 33342-332-15 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: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc.at 1-888-943-3210 or 1-855-926- 3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: July 2023; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Triamcinolone Acetonide ointment USP, 0.025% Rx only NDC: 33342-331-15 15 gms tube Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-15 15 gms carton Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-80 80 gms tube Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-80 80 gms carton Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-54 454 gms jar Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-15 15 gms tube Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-15 15 gms carton Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-80 80 gms tube Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-80 80 gms carton Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-54 454 gms jar Triamcinolone Acetonide ointment, 0.5% Rx only NDC: 33342-332-15 15 gms tube Triamcinolone Acetonide ointment, 0.5% Rx only NDC: 33342-332-15 15 gms carton 505 505 505 505 505 505 505 505 505 505 505 505

Package Descriptions
  • HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 gram tubes NDC 33342-331-15 80 gram tubes NDC 33342-331-80 454 g jar NDC 33342-331-54 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes NDC 33342-333-15 80 gram tubes NDC 33342-333-80 454 g jar NDC 33342-333-54 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 gram tubes NDC 33342-332-15 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: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc.at 1-888-943-3210 or 1-855-926- 3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: July 2023
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Triamcinolone Acetonide ointment USP, 0.025% Rx only NDC: 33342-331-15 15 gms tube Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-15 15 gms carton Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-80 80 gms tube Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-80 80 gms carton Triamcinolone Acetonide ointment, 0.025% Rx only NDC:33342-331-54 454 gms jar Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-15 15 gms tube Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-15 15 gms carton Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-80 80 gms tube Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-80 80 gms carton Triamcinolone Acetonide ointment, 0.1% Rx only NDC:33342-333-54 454 gms jar Triamcinolone Acetonide ointment, 0.5% Rx only NDC: 33342-332-15 15 gms tube Triamcinolone Acetonide ointment, 0.5% Rx only NDC: 33342-332-15 15 gms carton 505 505 505 505 505 505 505 505 505 505 505 505

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% or 0.5% contains 0.25 mg, 1 mg or 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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