FDA label 44e74fd3-7ce3-1115-e063-6394a90a864a

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
f22ba964-30f0-4b84-84af-9e67014de8d6
SPL ID
44e74fd3-7ce3-1115-e063-6394a90a864a
Version
12
Effective date
2025-12-01
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:42:40

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 Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, rinse thoroughly with water Avoid contact with eyes. If contact occurs, rinse thoroughly with water. For more severe cases, or if improvement is not apparent within 6-8 weeks, consult a health care professional. ​Know Adverse Reaction(s): ​ If you develop severe irritation, burning or itching of the skin, discontinue use and consult a health care professional. if you develop hives, swelling of the eyes and mouth, blistering or difficulty breathing, get medical help right away. When using this product Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. If irritation occurs, rinse thoroughly with water Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help right away

Reported adverse events (FAERS/openFDA)#

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