TRETINOIN
Generic: TRETINOIN
Basic Information
Manufacturer
Encube Ethicals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
b61f6b02-6171-4da8-94eb-bcd4808dd918
Indications & Usage
INDICATIONS AND USAGE Tretinoin gel is 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.
The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Warnings
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).
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).
Adverse Reactions
ADVERSE REACTIONS The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted.
If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate.
True contact allergy to topical tretinoin is rarely encountered.
Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin gel.
Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin gel.
To date, all adverse effects of tretinoin gel have been reversible upon discontinuance of therapy (see Dosage and Administration).
To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate.
True contact allergy to topical tretinoin is rarely encountered.
Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin gel.
Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin gel.
To date, all adverse effects of tretinoin gel have been reversible upon discontinuance of therapy (see Dosage and Administration).
To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.