FDA label 812bea2e-d4d5-8845-e053-2991aa0a32e7

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
822ed54c-da7d-4848-a6a0-51711911e4df
SPL ID
812bea2e-d4d5-8845-e053-2991aa0a32e7
Version
4
Effective date
2019-02-05
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 06:12:53

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. Do not cover with bandage. Do not use on wounds or damaged skin. Consult physician for children under 12. Do not use if you are allergic to Menthol Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days Or rash, itching or excessive skin irritation occurs.

Reported adverse events (FAERS/openFDA)#

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