warnings
WARNINGS GELS ARE FLAMMABLE. Note: Keep away from heat and flame. Keep tube tightly closed.
FDA label e06cc352-c119-4a1a-93cd-533b6a9971ec
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
- 6bb07b84-68bd-4513-b0cf-e2e949eaa964
- SPL ID
- e06cc352-c119-4a1a-93cd-533b6a9971ec
- Version
- 10
- Effective date
- 2018-01-10
- Source export date
- 2026-09-28
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:13:53
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 | e06cc352-c119-4a1a-93cd-533b6a9971ec | id | |
| spl set id | 6bb07b84-68bd-4513-b0cf-e2e949eaa964 | 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
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 dosing frequency should be adjusted temporarily to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies. True contact allergy to topical tretinoin is rarely encountered.Temporary hyper- or hypopigmentation has been reported with repeated application of AVITA ® Gel. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with AVITA ® Gel. Adverse effects of AVITA ® Gel have been reversible upon discontinuation of therapy (see Dosage and Administration Section).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.