Triamcinolone Acetonide Ointment USP, 0.025%, 0.1%, 0.5%

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:

str

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.

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

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.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS, General).

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.

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

Triamcinolone Acetonide Ointment USP, 0.025%
Rx only
NDC: 16714-267-01
15 gms tube
505
Triamcinolone Acetonide Ointment USP, 0.025%
Rx only
NDC:16714-267-01
15 gms carton

525
Triamcinolone Acetonide Ointment USP, 0.025%
Rx only
NDC:16714-267-02
80 gms tube

505
Triamcinolone Acetonide Ointment USP, 0.025%
Rx only
NDC:16714-267-02
80 gms carton

505
Triamcinolone Acetonide Ointment USP, 0.025%
Rx only
NDC:16714-267-03
454 gms jar

525
Triamcinolone Acetonide Ointment USP, 0.5%
Rx only
NDC: 16714-268-01
15 gms tube

505
Triamcinolone Acetonide Ointment USP, 0.5%
Rx only
NDC: 16714-268-01
15 gms carton

525

Triamcinolone Acetonide Ointment USP, 0.1%
Rx only
NDC: 16714-276-01
15 gms carton

505

Triamcinolone Acetonide Ointment USP, 0.1%
Rx only
NDC: 16714-276-01
15 gms tube

505

Triamcinolone Acetonide Ointment USP, 0.1%
Rx only
NDC: 16714-276-02
80 gms carton

505

Triamcinolone Acetonide Ointment USP, 0.1%
Rx only
NDC: 16714-276-02
80 gms tube

505

Triamcinolone Acetonide Ointment USP, 0.1%
Rx only
NDC: 16714-276-03
454 gm jar

505