TRETINOIN- tretinoin cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Available from:

Preferred Pharmaceuticals Inc.

INN (International Name):

TRETINOIN

Composition:

TRETINOIN 0.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tretinoin gel and cream are indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

Product summary:

Tretinoin Gel, USP Tretinoin Cream, USP NDC CODE Strength Qty. 68788-7039-2 0.05% 20 g

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRETINOIN- TRETINOIN CREAM
PREFERRED PHARMACEUTICALS INC.
----------
TRETINOIN GEL, USP AND TRETINOIN CREAM, USP
RX ONLY
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
PRESCRIBING INFORMATION
DES CRIPTION:
Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical
treatment of acne vulgaris. Each
gram of tretinoin gel contains tretinoin in either of two strengths,
0.025% (0.25 mg) or 0.01% (0.1 mg)
in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene,
and alcohol (denatured with tert-
butyl alcohol and brucine sulfate) 90% w/w. Each gram of tretinoin
cream contains tretinoin in either of
three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) in a
hydrophilic cream vehicle of:
stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl
alcohol, xanthan gum, sorbic acid,
butylated hydroxytoluene, and purified water. Chemically, tretinoin is
_all-trans_-retinoic acid. It has a
molecular weight of 300.44 and has the following structural formula:
CLINICAL PHARMACOLOGY:
Although the exact mode of action of tretinoin is unknown, current
evidence suggests that topical
tretinoin decreases cohesiveness of follicular epithelial cells with
decreased microcomedo formation.
Additionally, tretinoin stimulates mitotic activity and increased
turnover of follicular epithelial cells
causing extrusion of the comedones.
INDICATIONS AND USAGE:
Tretinoin gel and cream are indicated for topical application in the
treatment of acne vulgaris. The
safety and efficacy of the long-term use of this product in the
treatment of other disorders have not been
established.
CONTRAINDICATIONS :
Use of the product should be discontinued if hypersensitivity to any
of the ingredients is noted.
WARNINGS :
GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE. Keep out
of
reach of children. Keep tube tightly closed. Do not expose to heat or
store at temperatures above 120°F
(49°C).
PRECAUTIONS :
GENERAL:
If a reaction suggesting sensitivity or chemical irritation occurs,
use of the medication should be
d