ELLZIA PAK- triamcinolone acetonide, dimethicone kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Available from:

PureTek Corporation

INN (International Name):

TRIAMCINOLONE ACETONIDE

Composition:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone Acetonide Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations. ■ temporarily protects and helps relieve chapped or cracked skin

Product summary:

Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes: 15 g tube – NDC 52565-014-15 80 g tube – NDC 52565-014-80 1 lb (454 g) jar – NDC 52565-014-26 Store at 20° - 25°C (68° - 77°F). [see USP Controlled Room Temperature] Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 04/16

Authorization status:

unapproved drug other

Summary of Product characteristics

ELLZIA PAK- TRIAMCINOLONE ACETONIDE, DIMETHICONE
PURETEK CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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ELLZIA PAK™
(TRIAMCINOLONE ACETONIDE OINTMENT, DIMETHICONE)
THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED. THE INDIVIDUAL
PRODUCTS CONTAINED IN THIS PACKAGE SHOULD NOT BE USED ALONE OR IN
COMBINATION FOR OTHER
PURPOSES. THE INFORMATION DESCRIBED IN THIS LABELING CONCERNS ONLY THE
USE OF THESE PRODUCTS AS
INDICATED IN THIS ADMINISTRATION PACKAGE.
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%
DESCRIPTION
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. C
H
FO
. M.W. 434.51; CAS Reg. No. 76-25-5.
Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1mg
triamcinolone acetonide in an
ointment base of light mineral oil and white petrolatum.
CLINICAL PHARMACOLOGY
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.
PHARMACOKINETICS -
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including the vehicle, the integrity of the epidermal barrier, and the
use of occlusive dressings. Topical
corticosteroids can be absorbed from normal intact skin. Inflammation
and/or other disease processe