FDA.reportPublic FDA data

FDA label b5f83006-4dd3-4bad-b163-b8293d27c8e5

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
2bbc1a15-c95b-4a0b-a898-0e87a3f429e2
SPL ID
b5f83006-4dd3-4bad-b163-b8293d27c8e5
Version
1
Effective date
2016-06-30
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:55

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

Warning: For external use only. Flammable: Keep away from excessive heat or open flames. Ask a doctor before using if you have: Sensitive skin If pregnant or breast feeding: Ask a health professional before use. When using this product: • Avoid contact with eyes or mucous membrane. • Do not apply to wounds or damaged skin. • Do not use with other ointments, creams, sprays or liniments. • Do not apply to irritated skin or if excessive irritation develops. • Do not bandage. • Wash hands after use with cool water • Do not use with heating pad or device. Stop use and ask a doctor if: Condition worsens or if symptoms persist for more than 7 days or clear up and reoccur.

Reported adverse events (FAERS/openFDA)#

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