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
- 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
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 97b689a2-90b2-0413-e053-2a95a90a428d | id | |
| spl set id | e61bce4c-773d-4bdf-953d-e4fc56ebe179 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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.