Triamcinolone Acetonide Ointment
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes: 15 g tube – NDC 52565-014-15 80 g tube – NDC 52565-014-80 1 lb (454 g) jar – NDC 52565-014-26 STORAGE Store at 20° - 25°C (68° - 77°F). [see USP Controlled Room Temperature] Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 04/16; Ellzia Pak™ - carton: Packaged in the USA by: PureTek Corporation San Fernando, CA 91340 For questions or information call toll-free: 877-921-7873 Rev. 36773 image description
- HOW SUPPLIED Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes: 15 g tube – NDC 52565-014-15 80 g tube – NDC 52565-014-80 1 lb (454 g) jar – NDC 52565-014-26 STORAGE Store at 20° - 25°C (68° - 77°F). [see USP Controlled Room Temperature] Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 04/16
- Ellzia Pak™ - carton: Packaged in the USA by: PureTek Corporation San Fernando, CA 91340 For questions or information call toll-free: 877-921-7873 Rev. 36773 image description
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. C 24 H 31 FO 6 . M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1mg triamcinolone acetonide in an ointment base of light mineral oil and white petrolatum. image description
Indications & Usage
Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Uses ■ temporarily protects and helps relieve chapped or cracked skin
Dosage & Administration
Apply a thin film 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. Directions ■ apply cream liberally as needed
Warnings & Precautions
Warnings For external use only Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not get into eyes Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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. To report SUSPECTED ADVERSE REACTIONS , contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Purpose
Purpose Skin Protectant
Do Not Use
Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns
When Using
When using this product ■ do not get into eyes
Stop Use & Ask a Doctor
Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage & Handling
STORAGE Store at 20° - 25°C (68° - 77°F). [see USP Controlled Room Temperature] Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 04/16 Other information ■ protect from freezing ■ avoid excessive heat
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