TRETINOIN cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

TRETINOIN

Composition:

TRETINOIN 0.1 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 Cream, USP NDC CODE     Strength           Qty.      21695-805-20     0.05%           20 g Tretinoin Cream, USP: store below 27°C (80°F) Manufactured for Rouses Point Pharmaceuticals, LLC By DPT Laboratories, San Antonio, TX 78215 Repackaged by Rebel Distributors Corp, Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRETINOIN- TRETINOIN CREAM
Rebel Distributors Corp
----------
PATIENT INSTRUCTIONS
Acne Treatment
IMPORTANT
Read Directions Carefully Before Using
Read Directions Carefully Before Using.
THIS LEAFLET TELLS YOU ABOUT TRETINOIN ACNE TREATMENT AS PRESCRIBED BY
YOUR PHYSICIAN. THIS PRODUCT IS TO BE USED ONLY ACCORDING TO YOUR
DOCTOR'S
INSTRUCTIONS, AND IT SHOULD NOT BE APPLIED TO OTHER AREAS OF THE BODY
OR TO
OTHER GROWTHS OR LESIONS. THE LONG-TERM SAFETY AND EFFECTIVENESS OF
THIS
PRODUCT IN OTHER DISORDERS HAVE NOT BEEN EVALUATED. IF YOU HAVE ANY
QUESTIONS, BE SURE TO ASK YOUR DOCTOR.
WARNINGS
TRETINOIN 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
The effects of the sun on your skin. As you know, overexposure to
natural sunlight or the artificial
sunlight of a sunlamp can cause sunburn. Overexposure to the sun over
many years may cause premature
aging of the skin and even skin cancer. The chances of these effects
occurring will vary depending on
skin type, the climate and the care taken to avoid overexposure to the
sun. Therapy with tretinoin may
make your skin more susceptible to sunburn and other adverse effects
of the sun, so unprotected exposure
to natural or artificial sunlight should be minimized.
Laboratory findings. When laboratory mice are exposed to artificial
sunlight, they often develop skin
tumors. These sunlight-induced tumors may appear more quickly and in
greater number if the mouse is
also topically treated with the active ingredient tretinoin. In some
studies, under different conditions,
however, when mice treated with tretinoin were exposed to artificial
sunlight, the incidence and rate of
development of skin tumors was reduced. There is no evidence to date
that tretinoin alone will cause the
development of skin tumors in either laboratory animals or humans.
However, investigations in this area
are continuing.
Use caution in the sun. When outsid

Summary of Product characteristics

TRETINOIN- TRETINOIN CREAM
REBEL DISTRIBUTORS CORP
----------
TRETINOIN GEL, USP
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
discontinued. Exposu