Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g 63 g (NDC 45802- 045 -01) aerosol can. 100 g (NDC 45802- 045 -02) aerosol can.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 g Carton Rx Only Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g with Spray Tube For dermatologic use only Not for ophthalmic use Read all sides 100 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization-template
- HOW SUPPLIED Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g 63 g (NDC 45802- 045 -01) aerosol can. 100 g (NDC 45802- 045 -02) aerosol can.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 g Carton Rx Only Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g with Spray Tube For dermatologic use only Not for ophthalmic use Read all sides 100 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization-template
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: A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant. Chemical Structure
Indications & Usage
Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Dosage & Administration
Directions for use of the spray can are provided on the label. The preparation may be applied to any area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided. Spray is flammable; avoid heat, flame or smoking when using this product. Three or four applications daily of Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g are generally adequate.
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.
Storage & Handling
Storage and Handling Store at room temperature; avoid excessive heat. Contents under pressure; do not puncture or incinerate. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured By Padagis, Yeruham, Israel Distributed By Padagis TM , Allegan, MI 49010 • www.padagis.com Rev 03-22 6K700 RC J3
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