TRIAMCINOLONE ACETONIDE LOTION, USP 0.025%, FOR TOPICAL USE ONLY

/TRIAMCINOLONE ACETONIDE LOTION, USP 0.025%, FOR TOPICAL USE ONLY
TRIAMCINOLONE ACETONIDE LOTION, USP 0.025%, FOR TOPICAL USE ONLY2018-09-06T09:12:40+00:00

Prescription Drug Name:

TRIAMCINOLONE ACETONIDE LOTION, USP 0.025%, FOR TOPICAL USE ONLY

ID:

47121b80-2218-41c2-bd76-70e945fb8d9b

Code:

34391-3

DESCRIPTION


id: db729730-4203-44b3-b8d2-6b704b10c3dd
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Triamcinolone Acetonide Lotion, USP is supplied in the following strengths: 0.025%, 0.1%. Each mL of Triamcinolone Acetonide Lotion, USP, 0.025% contains 0.25 mg triamcinolone acetonide, USP in a lotion base containing citric acid anhydrous, cetyl alcohol, dimethicone, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate, and stearyl alcohol. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. 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:

CLINICAL PHARMACOLOGY


id: 2a1a7a0a-da0e-432b-a3d7-d236e078cc37
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: 7bda1e9c-3645-4a9b-8b10-2bbc879c05ca
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: db021bd0-a904-48ec-a4ec-d6a54c986aad
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 preparation.

ADVERSE REACTIONS


id: 80bc804b-a2cd-42f4-8e93-0308fd829093
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 Hypertrichosis Maceration of the skin
Itching Acneiform eruptions Secondary infection
Irritation Hypopigmentation Skin Atrophy
Dryness Perioral dermatitis Striae
Folliculitis Allergic contact dermatitis Miliaria

OVERDOSAGE


id: ab9128a5-4e03-4106-a02b-ba69df954398
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: 42369663-0e59-4147-85ab-ec08cbb5bc73
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.

HOW SUPPLIED


id: 96a62077-76ed-4f93-9271-1e8b882c305b
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Lotion, USP 0.025% is supplied in the following size: 2 fl oz (60 mL) bottles

PRINCIPAL DISPLAY PANEL – 60 mL Bottle Label


id: ae7f10be-3c65-4c5b-8570-fb5215d9940d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

MGP NDC 60432-560-60 TRIAMCINOLONE
ACETONIDE
LOTION, USP 0.025%
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
Rx Only NET: 2 fl oz (60 mL)