FDA label cfe3a96c-6b75-19cf-e053-2a95a90acf88

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
40cd0087-6537-4451-9d1c-cbaf6d596925
SPL ID
cfe3a96c-6b75-19cf-e053-2a95a90acf88
Version
7
Effective date
2021-11-03
Source export date
2026-11-06
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/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:51:49

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 and cautions

Prolonged or frequent use may result in a permanent discoloration of the skin. Federal law prohibits dispensing without a prescription. For Physician use only. Keep out of reach of children. For external use only. Harmful if taken internally. If swallowed, do not induce vomiting. Give large quantities of water. Never give anything by mouth to an unconscious person. If inhaled, remove to fresh air. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Wash clothing before reuse. In all cases get medical attention immediately.

Reported adverse events (FAERS/openFDA)#

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