FDA.reportPublic FDA data

FDA label 8f4b4b68-cff8-4011-af61-bc512ca21264

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
52f5a3c0-8d57-4075-bb7c-ecb36a353e5a
SPL ID
8f4b4b68-cff8-4011-af61-bc512ca21264
Version
2
Effective date
2015-01-23
Source export date
2026-11-06
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/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:05:37

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. When using this product and other topical acne medications at the same time or immediately following use of the product, dryness or irritation of the skin may be increased. If this occurs, only one medication should be used unless directed by a doctor. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.