TRIAMCINOLONE ACETONIDE

Topical corticosteroids, such as Triamcinolone Acetonide 0.05% in Absorbase ® (Triamcinolone Acetonide Ointment, USP), constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Each gram of Triamcinolone Acetonide 0.05% in Absorbase ® (Triamcinolone Acetonide Ointment, USP) contains 0.5 mg of Triamcinolone Acetonide USP in a water-in-oil emulsion composed of Light Mineral Oil NF, Purified Water USP, White Petrolatum USP, Heavy Mineral Oil USP, Mineral Wax, and Lanolin Alcohols NF. The white ointment is for topical use only. Triamcinolone Acetonide has the molecular formula of C 24 H 31 FO 6 and is designated chemically as Pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-, (11β, 16α)-. It has a molecular weight of 434.50 and the following structural formula: Chemical Structure

Triamcinolone Acetonide 0.05% in Absorbase ® (Triamcinolone Acetonide Ointment, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

Apply a thin film to the affected area two to four times a day. 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 0.05% in Absorbase ® (Triamcinolone Acetonide Ointment, USP) is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] DISPENSE IN A WELL-CLOSED CONTAINER. Rx Only For external use only. Not for ophthalmic use.