Prescription Drug Name:

Triamcinolone Acetonide Ointment USP, 0.025%, 0.1%, 0.5%

ID:

a986cc20-ac47-42e9-b77d-72995bd70468

Code:

34391-3

DESCRIPTION


id: b8071767-29a9-4a94-a8cd-fa0914f74ddc
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)]-, (11β,16α)-. C24H31FO6, M.W. 434.51; CAS Reg. No. 76-25-5. Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or 0.5% contains 0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.

CLINICAL PHARMACOLOGY


id: a5d3820c-fdf7-4b03-81f3-fc413a747141
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: 9a364028-ab9b-4a50-99b1-c331108ae1e5
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: 98039394-70de-462e-892a-6cdc0e6875d7
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: 590eb05f-b7a5-450f-b768-79f456aae1a3
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: fcac8273-92f6-4d2f-b58d-4536bf10ea67
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: f9af473d-4f64-4851-a5d2-15ba1b001bbe
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: ab90144c-0eb4-4e09-8588-b6d9bee918ae
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 g tube (NDC 45802-054-35) 80 g tube (NDC 45802-054-36) 454 g jar (NDC 45802-054-05) Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 g tube (NDC 45802-055-35) 80 g tube (NDC 45802-055-36) 454 g jar (NDC 45802-055-05) Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 g tube (NDC 45802-049-35)

STORAGE


id: 6a4b28e0-ceda-4707-9013-3829574b7485
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Principal Display Panel – 0.025%


id: 0a1916aa-9326-44aa-bbeb-7a84a656bbbe
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only Triamcinolone Acetonide Ointment USP, 0.025% NET WT 80 g

Principal Display Panel – 0.1%


id: 60f8be48-3f4c-424c-bdc6-a18aa5dbca20
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only Triamcinolone Acetonide Ointment USP, 0.1% NET WT 80 g

Principal Display Panel – 0.5% Carton


id: bf11bfee-bc60-4c3e-aadd-bf305a95107f
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only Triamcinolone Acetonide Ointment USP, 0.5% NET WT 15 g