FDA label 8a63f38f-085a-4a7b-9dd2-a9c0c2ed827e

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
b11d93b9-39e1-46b5-ae7f-cbb5885e87e2
SPL ID
8a63f38f-085a-4a7b-9dd2-a9c0c2ed827e
Version
3
Effective date
2025-04-21
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 06:27:15

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 Do not use • on wounds or on irritated or damaged skin • with a heating pad When using this product • use only as directed • do not bandage tightly • avoid contact with eyes and mucous membranes • do not expose the area to local heat or to direct sunlight • rare cases of serious burns have been reported with products of this type • a transient burning sensation may occur upon application but generally disappears in several days • avoid applying into skin folds Stop use and ask a doctor if • condition worsens or symptoms persist for more than 7 days • symptoms clear up and occur again within a few days • redness is present or excessive skin irritation occurs • your child experiences severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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