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 ).
FDA label 5441b045-c22c-47f7-8bdd-e46f8c35aa9e
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
- SPL set ID
- ab54603f-c270-4737-8ba0-a4f7e15465ad
- SPL ID
- 5441b045-c22c-47f7-8bdd-e46f8c35aa9e
- Version
- 2
- Effective date
- 2014-10-14
- Source export date
- 2026-08-08
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-08/c371bcf53af83126908f941c4bb6f83aeaa6e2ef3749f9f7be6c7a3681e3b333/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
- Import run
- 20260810T161303Z
- Imported at
- 2026-08-10 16:24:51
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 |
|---|---|---|---|
| spl id | 5441b045-c22c-47f7-8bdd-e46f8c35aa9e | id | |
| spl set id | ab54603f-c270-4737-8ba0-a4f7e15465ad | set_id |
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
The skin if certain sensitive individuals may become excessively red, edamatous, 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 susceptibility to sunlight while under treatment with tretinoin. To date, alldverse effects of tretinoin have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION Section)