DESCRIPTION
id: f842791a-1593-4b74-ab9a-85fdf7202b72
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis (oxy)]-,(11ß,16α)-. C24H31FO6, and M.W. of 434.51; CAS Reg. No. 76-25-5.
Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP contains 0.25 mg, 1 mg, or 5 mg triamcinolone acetonide respectively, in a washable cream base of cetyl alcohol, cetyl esters wax, glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60, propylene glycol, purified water, sorbic acid, and sorbitan monostearate.
CLINICAL PHARMACOLOGY
id: d7818735-8a78-45a7-ab48-990052d68f85
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Topical corticosteroids share anti-inflammatory, anti-pruritic 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.
INDICATIONS AND USAGE
id: 318778cd-614e-4d71-82e1-1a4200c5375f
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
id: a584b72b-e1ae-47d3-8e91-c7186d09c179
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 of the preparations.
ADVERSE REACTIONS
id: 6e02d3e2-9370-49c9-9d65-e6a960b0f593
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. 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.
OVERDOSAGE
id: 14984676-aec1-4333-867b-1c185e363fb2
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see
PRECAUTIONS
).
DOSAGE AND ADMINISTRATION
id: 86d9a8dd-4201-4f9a-9187-3e48b0596f86
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.
Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressing should be discontinued and appropriate antimicrobial therapy instituted.
HOW SUPPLIED
id: d2d8e1ea-164f-498c-b288-1fcc2b60f9f2
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Triamcinolone Acetonide Cream USP, 0.025% is available as follows:
15 g tube (NDC 45802-063-35)
80 g tube (NDC 45802-063-36)
454 g jar (NDC 45802-063-05)
Triamcinolone Acetonide Cream USP, 0.1% is available as follows:
15 g tube (NDC 45802-064-35)
80 g tube (NDC 45802-064-36)
454 g jar (NDC 45802-064-05)
Triamcinolone Acetonide Cream USP, 0.5% is available as follows:
15 g tube (NDC 45802-065-35)
STORAGE
id: 76f0cca2-9eeb-472d-9ca3-4168fef9af7a
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Manufactured By Perrigo
Bronx, NY 10457
Distributed By Perrigo
Allegan, MI 49010 • www.perrigo.com
Rev 08-15
: 4B400 RC JX1
Principal Display Panel – 0.025% Carton
id: 175e056f-2a67-4f08-9566-32f638ddfd89
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Rx Only
Triamcinolone Acetonide Cream USP, 0.025%
NET WT 15 g
Principal Display Panel – 0.5% Carton
id: 7367fd43-6dc3-4a06-bba7-4b79f1d74970
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Rx Only
Triamcinolone Acetonide Cream USP, 0.5%
NET WT 15 g
Package/Label Display Panel – 0.1% Carton
id: 05f34e59-035e-4c22-bdc3-cc48fc052bd7
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Rx Only
Triamcinolone Acetonide Cream USP, 0.1%
NET WT 15 g
