displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Each mL of Triamcinolone Acetonide Lotion, USP, 0.1% contains 1 mg triamcinolone acetonide USP in a lotion base containing cetyl alcohol, polysorbate 20, propylene glycol, purified water, simethicone, sorbitan monopalmitate, and stearyl alcohol.
Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone.
The molecular formula is C24H31FO6. It has the following structure:
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
Topical corticosteroids share anti-inflammatory, antipruritc 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
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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of components of the preparation.
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:
||Allergic contact dermatitis
||Maceration of the skin
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Topical corticosteroids are generally applied to the affected area as a thin film from three to four times daily depending on the severity of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Triamcinolone Acetonide Lotion USP, 0.1% is supplied in the following size: 60 mL bottles – NDC 52565-011-59.
PRINCIPAL DISPLAY PANEL – 60 mL Bottle Carton
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4
Lotion USP, 0.1%
For External Use Only
Not For Ophthalmic Use