FDA label 88ef4ebe-85fe-4fcd-8172-e685173859b5

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID
ee922f41-47f0-4845-9907-0661f20087a7
SPL ID
88ef4ebe-85fe-4fcd-8172-e685173859b5
Version
2
Effective date
2014-10-14
Source export date
2026-08-01
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/2026-08-01/5cbbf4af8f4e275ec50931155b30ffa7322568b9af8a1c936a47f6d6774862fd/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:02:37

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

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 ).

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

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)