FDA.reportPublic FDA data

FDA label 6492c511-c484-c337-e053-2a91aa0a3916

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
6492c511-c483-c337-e053-2a91aa0a3916
SPL ID
6492c511-c484-c337-e053-2a91aa0a3916
Version
2
Effective date
2018-02-06
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:23:32

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. Use only as directed. Avoid contact with eyes and mucous membranes or genitals. Do not cover or tightly bandage area. on wounds or damaged skin. Do not use with heating pad. Do not use On cuts or infected skin, on children less than 12 years old in large amount. STOP USE AND ASK A PHYSICIAN: For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If itching or rash occurs. Keep out of reach of children. Consult physician for children under 12.

Reported adverse events (FAERS/openFDA)#

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