FDA.reportPublic FDA data

FDA label 9767c2fa-2e78-255a-e053-2a95a90ac88c

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
476aeb71-b97a-59fb-e054-00144ff8d46c
SPL ID
9767c2fa-2e78-255a-e053-2a95a90ac88c
Version
5
Effective date
2019-11-15
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:12:06

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 Section For External Use Only Do not use on: broken skin large areas of the skin When using this product: apply only to areas with acne do not get into eyes if excessive skin irritation develops or increases, disconstinue use and consult a physician using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used otherwise directed by a physician. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center Keep Out of Reach of Children Keep Out of Reach of Children. If swallowed get medical help or contact a Poison Control Center

Reported adverse events (FAERS/openFDA)#

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