FDA label 748f638e-f2f4-4f75-b9bf-a46c8fac01e9

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
47083271-4584-445a-be2d-c80b34503cc0
SPL ID
748f638e-f2f4-4f75-b9bf-a46c8fac01e9
Version
6
Effective date
2018-01-02
Source export date
2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:44

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. Directions • strip off the polyethylene film and place adhesive pad over affected area • change pad 1 or 2 times a day • not for children under 4 years Other information • keep container tightly closed • store at room temperature (20 - 25 degrees C or 68 - 77 degrees F) Inactive ingredients carbomer 910, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, polysorbate 80, sorbitan monolaurate, sorbitol, tartaric acid, titanium dioxide, water

Reported adverse events (FAERS/openFDA)#

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