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 (canonical bytes are SHA-256 checked before publication)

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

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

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#

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

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%​ Patch​s 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.