warnings
WARNINGS Keep out of reach of children. Keep tube tightly closed. Do not expose to heat. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between l5°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Tretinoin
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Tretinoin
- Generic name
- TRETINOIN
- Manufacturer
- Viona Pharmaceuticals Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd
- SPL ID
- 97ba2e16-fc52-495e-bc88-84f93170ca07
- Version
- 1
- Effective date
- 2024-04-26
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:07:05
| Harmonized routes |
|---|
| TOPICAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | ANDA | 218561 | derived:openfda.application_number |
| application number | ANDA218561 | openfda.application_number | |
| brand name | Tretinoin | openfda.brand_name | |
| generic name | TRETINOIN | openfda.generic_name | |
| manufacturer name | Viona Pharmaceuticals Inc | openfda.manufacturer_name | |
| ndc | package | 72578-153-09 | openfda.package_ndc |
| ndc | package | 72578-153-08 | openfda.package_ndc |
| ndc | product | 72578-153 | openfda.product_ndc |
| ndc11 | package | 72578015308 | derived:openfda.package_ndc |
| ndc11 | package | 72578015309 | derived:openfda.package_ndc |
| rxcui | 198300 | openfda.rxcui | |
| spl id | 97ba2e16-fc52-495e-bc88-84f93170ca07 | id | |
| spl set id | 2ee7844c-e5ee-4d15-80c7-c07a9f23ccdd | set_id | |
| unii | 5688UTC01R | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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 Viona Pharmaceuticals Inc., at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.