FDA label ec822cf0-0f1c-0d60-e053-2995a90a3fdf
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
- ac4eba14-1bf9-7821-e053-2995a90a9a64
- SPL ID
- ec822cf0-0f1c-0d60-e053-2995a90a3fdf
- Version
- 8
- Effective date
- 2022-11-02
- Source export date
- 2026-09-28
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:23:28
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 | ec822cf0-0f1c-0d60-e053-2995a90a3fdf | id | |
| spl set id | ac4eba14-1bf9-7821-e053-2995a90a9a64 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings: For external use only. Use only as directed or by a health professional. Do not use: On wounds, cuts, damaged or infected skin. - On eyes, mouth, genitals, or any other mucus membranes. Stop and consult your physician if pregnant or if pain worsens Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use.
warnings and cautions
WARNINGS: Do not use: On wounds, cuts, damaged or infected skin On eyes, mouth, genitals, or other mucous membranes Consult physician for children under 12 years of age Stop and consult your prescriber if pain worsens DISCONTINUE USE AT LEAST 1 HOURS BEFORE A BATH OR SHOWER AND DO NOT USE IMMEDIATELY AFTER A BATH OR SHOWER Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you: Shortness of breath Swelling or numbness of the tongue or throat Severe headache or vomiting Dizziness or faintness Changes in vision or speech This is not a complete list of the possible side effects. For more information, talk with your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time. Serious adverse experiences following the administration of Menthol 4.5% Capsaicin 0.0225% Patchs are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.