Levatio Patch Package Insert

The prescribing information is written for health professionals. Plain-language information for patients can be found in the patient information: dosage.

Prescribing information (package insert) - Levatio Patch

Active Ingredient

Menthol 5.00 %

Capsaicin 0.03 %

Other Ingredients:

acrylic acid ,aluminum hydroxide . carmellose sodium 2-ethylexyl acrylate glycerin . isopropyl myristate .methyl acrylate

nonoxynol-30 .poluacrylate.polyacrylic acid .polysorbate 80 sorbitan sesquioleate strach .talc .tartaric acid

.titanium dioxide .water(254-114)

Purpose

External Analgesic

Uses:

For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains,

bruises and sprains

Warnings:

For external use only
Avoid contact with eyes
Do not apply to open wounds or damages skin
If symptoms persist for more than seven days, discontinue use and consult physician
Keep out of reach of children. If swallowed, consult physician.
Do not bandage tightly
If pregnant or breast feeding, contact physician prior to use

Directions:

Clean and dry affected area
Remove patch from backing and apply to affected area. Apply directly to affected area.
Use only on patch at a time, and a maximum of four patches per day.
Leave patch of affected area for up to eight hours.
Do not use patches for more than five consecutive days
Children under 12 should consult a physician prior to use.

Store at room temperature. Avoid direct sunlight.

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Levatio Patch

Rx or OTC

Prescription (Rx)?

This drug is available only with a prescription from a licensed healthcare provider.
Rx

Active ingredients

Menthol 5 g/100 g, Capsaicin 0.03 g/100 g

Dosage form

Patch

Route

Topical

Marketing status

not in the current FDA NDC Directory

Company (applicant)

Alivio Medical Products, LLC

FDA approval

UNAPPROVED DRUG OTHERUnapproved drug

Manufacturers

1 labelers list this drug on DailyMed

Packages (NDC)

Package
5 g/100 g, .03 g/100 g – 8.5 g in 1 patch / 15 in 1 box NDC 69512-010-02

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.