FDA.reportPublic FDA data

FDA label 3165a1c3-b39e-0faa-e054-00144ff8d46c

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
310198a7-eb46-57e6-e054-00144ff88e88
SPL ID
3165a1c3-b39e-0faa-e054-00144ff8d46c
Version
2
Effective date
2016-04-26
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:00:48

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

WARNINGS FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION 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 UNLESS DIRECTED BY A DOCTOR. Keep out of reach of children IF SWALLOWED, GET MEDICATL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

warnings

WARNINGS FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATION 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 WHOULD BE USED UNLESS DIRECTED BY A DOCTOR. Keep out of reach of children. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

warnings

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

Reported adverse events (FAERS/openFDA)#

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