Tretinoin
Generic: TRETINOIN
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
04f14d6e-5b44-44bd-a7f3-d684d9c5d7cb
Indications & Usage
Indications and Usage Tretinoin 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.
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.
Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin.
To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION ).
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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.
Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin.
To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION ).
To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.