FDA label 97b689a2-90b2-0413-e053-2a95a90a428d

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
e61bce4c-773d-4bdf-953d-e4fc56ebe179
SPL ID
97b689a2-90b2-0413-e053-2a95a90a428d
Version
1
Effective date
2019-11-19
Source export date
2026-09-28
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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:55

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings: Only for external use. Use only as directed or by a health professional. Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucus membranes. Do not cover with bandage. Keep out of reach of children. Consult physician for children under 12. Consult your physician: if pregnant or pain persists or worsens.

warnings and cautions

Warnings and Precautions • For external use only. Use only as directed or by a health professional. • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucus membranes. •Do not cover with bandage. •Consult your physician: if pregnant or if pain persists and/or worsens •Consult your physician: if pain persists or worsens or if using any other topical pain products. • Store in a dry, cool place

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions Even though adverse reactions are rare, a very small percentage of patients experience an unpleasant burning sensation, redness, warmth, or stinging. Please be aware of any unpleasant side effects as described. If any of these effects persists or worsens, contact your physician or pharmacist immediately. This medication is not absorbed systemically but if any serious side effects (i.e. rash, itching/swelling, severe dizziness) are experienced, discontinue use immediately and contact your pharmacist or physician. This is not a complete list of all side effects that may occur. You may report side effects to the FDA at 800-FDA-1088 or at http://www.fda.gov/medwatch

Reported adverse events (FAERS/openFDA)#

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