Triamcinolone Acetonide, Cream USP, 0.1%

DESCRIPTION

id: bae586f2-e484-4aff-bb38-1a0ffb5b8828
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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. With the molecular formula of C₂₄H₃₁FO₆ and a molecular weight of 434.51. The structural formula is:
Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide in a cream base consisting of cetyl alcohol, cetyl esters wax, glyceryl monostearate, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.

CLINICAL PHARMACOLOGY

id: 14ab13ee-8fb4-42fb-a6e7-96a68a4216f6
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.The mechanism of anti-inflammatory activity of 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.

INDICATIONS AND USAGE

id: 8a39bdd6-d30b-4697-8835-9ab0157ef3a7
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

id: df9ec70d-7d14-4ad9-811d-b967f6c99743
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

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

ADVERSE REACTIONS

id: 001606cf-f60e-4655-88d5-6adba2ed1cec
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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.

OVERDOSAGE

id: e54a946f-df52-4feb-8306-41cb14604c9f
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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

DOSAGE AND ADMINISTRATION

id: 1b187013-92b8-41d7-9a3d-50965029d653
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Apply to affected area two or three times daily. Rub in gently.

HOW SUPPLIED

id: 8302a6da-e759-4c19-ad1f-07c5806464c9
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Cream USP, 0.1% in 30g tube (NDC: 35356-753-30).

Image of Label

id: 0d0b3503-ff9e-43b0-84f6-c3c3105b7c68
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4