TriamcinoloneAcetonideTopical Aerosol USP, 0.147 mg/g

/TriamcinoloneAcetonideTopical Aerosol USP, 0.147 mg/g
TriamcinoloneAcetonideTopical Aerosol USP, 0.147 mg/g2018-09-06T09:12:40+00:00

Prescription Drug Name:

TriamcinoloneAcetonideTopical Aerosol USP, 0.147 mg/g

ID:

b07ff7e1-0770-4d4b-b775-68c2bd522e21

Code:

34391-3

DESCRIPTION


id: cd66f12d-c049-48f7-9392-c70780a63f7e
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. The structural formula is: A two-second application, which covers an area approximately the size of the hand, delivers an amount of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the nonvolatile vehicle remaining on the skin contains approximately 0.2% triamcinolone acetonide. Each gram of spray provides 0.147 mg triamcinolone acetonide in a vehicle of isopropyl palmitate, dehydrated alcohol (10.3%), and isobutane propellant.

CLINICAL PHARMACOLOGY


id: 9cb97905-f4d5-4c6c-9d24-f0b31aa79606
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 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: 48204e41-6eac-4c77-84a7-58cb45f77d5c
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS


id: 288c7875-c053-4bd6-a3e9-30c083fd71bd
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: 523abe0b-bea7-462d-8a8c-0c6236e31a5a
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: f9eb32a9-0a30-4014-aed3-1f702b409928
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: 16e55e3e-a36c-42c9-9440-af2407bac2a5
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Directions for use of the spray can are provided on the label. The preparation may be applied to any area of the body, but when it is sprayed about the face, care should be taken to see that the eyes are covered, and that inhalation of the spray is avoided. Spray is flammable; avoid heat, flame or smoking when using this product. Three or four applications daily of Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g are generally adequate.

HOW SUPPLIED


id: 9d52f01c-5b49-49cf-806f-cad44ca698bd
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone
Acetonide
Topical Aerosol USP, 0.147 mg/g
63 g (NDC 45802-045-01) aerosol can. 100 g (NDC 45802-045-02) aerosol can.

Storage and Handling


id: eeac6889-cf5a-41f1-a6ab-617ca9fb2a6e
displayName: STORAGE AND HANDLING SECTION
FDA Article Code: 44425-7

Store at room temperature; avoid excessive heat. Contents under pressure; do not puncture or incinerate. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Made in Israel Manufactured By Perrigo, Yeruham 80500, Israel Distributed By Perrigo, Allegan, MI 49010 • www.perrigo.com Rev 05-13 : 6K700 RC J1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 63 g Carton


id: 1cefd09f-b19b-430f-9293-d4364b8ad599
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g with Spray Tube For dermatologic use only Not for ophthalmic use Read all sides

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 63 g Label


id: 1b9d45d7-a40d-4f01-9a59-45dbd286c3cb
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g with Spray Tube For dermatologic use only Not for ophthalmic use

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 g Carton


id: c2643308-0c02-48ba-ad08-9a616f19f9a6
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g with Spray Tube For dermatologic use only Not for ophthalmic use Read all sides

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 100 g Label


id: 52e640a7-e8ec-41e9-b3ac-0fca8058b644
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

Rx Only Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g with Spray Tube For dermatologic use only Not for ophthalmic use