FDA label e5e2a5f8-7cb2-4b49-8f5e-7658780dde5e

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
83d572a1-7189-429f-ae13-3c9aa9cd6bd9
SPL ID
e5e2a5f8-7cb2-4b49-8f5e-7658780dde5e
Version
2
Effective date
2017-12-31
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:59:40

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 irritated, broken, or damaged skin ■ on wounds ■ otherwise than as directed When using this product ■ avoid contact with the eyes or mucous membranes ■ do not bandage the area tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles) because doing so can increase the risk of serious burns Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive irritation of the skin develops ■ nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs ■ when using for pain of arthritis: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age ■ you experience pain, swelling, or blistering of the skin (this product should not cause pain or skin damage) Warning - Rare cases of serious burns have been reported to occur on the skin where OTC external analgesics were applied. Read and follow all directions and warnings on this label. Keep out of reach of children to avoid accidental poisoning. 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.