Levatio Patch

LEVATIO PATCH — menthol and capsaicin patch
Alivio Medical Products, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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.

Leveatio — menthol and capsaicin patch

Levatio Patch

Description

Levatio Patch contains capsaicin and menthol in a

localized topical dermal delivery system. The

capsaicin in Levatio is a synthetic equivalent of the

naturally occurring compound found in chili

peppers. Capsaicin is soluble in alcohol, acetone,

and ethyl acetate and very slightly soluble in water.

The menthol is slightly soluble in water.

Levatio is a single-use patch stored in a foil pouch.

Each Levatio patch is 8 cm x 12 cm and consists

of a polyester backing film coated with a

drug-containing silicone adhesive formulation,

and covered with a removable polyester release liner.

The empirical formula for capsaicin is C18H27NO31

with a molecular weight of 305.42. The chemical compound capsaicin

[(E)-8-methyl-N-vanillyl-6-nonenamide] is an

activating ligand for transient receptor

potential vanolloid 1 receptor (TRPV1)

The empirical formula for menthol is C10H20)1 with a

molecular weight of 156.27. The chemical compound menthol

[(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol] is an activating

ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8).

Each Levatio Patch contains 0.03% capsaicin (0,03

grams of capsaicin per patch) and 5% menthol (5 grams of menthol per patch). The Levatio Patch

contains the following inactive ingredients: acrylic acid, aluminum hydroxide, carmellose sodium

2-ethylexyl acrylate, glycerin, isopropyl myristate,

methyl acrylatenonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80 sorbitan

sesquioleate starch, talc, tartaric acid, titanium dioxide, water (245-114).

INDICATIONS AND USAGE

Levatio Patch is indicated for the temporary relief of minor aches and muscle pains

associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Levatio Patch is an external analgesic/countrerirritant.

CONTRAINDICATIONS

Levatio Patch is indicated for those patients with a history of hypersensitivity

to any of the components of the preparation.

WARNINGS

*FOR EXTERNAL USE ONLY

*USE ONLY AS DIRECTED

*AVOID CONTACT WITH EYES AND MUCOUS MEMBRANES,

*DO NOT COVER WITH BANDAGE

*DO NOT USE ON WOUNDS OR DAMAGED SKIN.

*CONSULT PHYSICIAN FOR CHILDREN UNDER 12

DO NOT USE IF YOU ARE ALLERGIC TO MENTHOL.

*STOP USE AND ASK A DOCTOR IF SYMPTOMS PERSIST FOR MORE THAN

7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS OR RASH,

ITCHING OR EXCESSIVE SKIN IRRITATION OCCURS.

*KEEP OUT OF REACH OF CHILDREN.

DOSAGE AND ADMINISTRATION

Levatio Patch contains 0.03% capsaicin and 5.00% menthol. Instructions for use

*Clean and dry affected area

*Cut open pouch and remove pouch

*Remove protective film and apply directly to area of pain

*Apply to affected area not more than 3 times daily

*Wash hands with soap after applying patch

*Reseal pouch containing unused patches

DIRECTIONS

Adults and children 12 years and over — apply to affected area change patch 1 to 2 times daily

Children under 12 years — Consult physician before use

HOW SUPPLIED

Levatio Patch is supplied in 3 re-sealable pouches each containing 5 patches. NDC 69512-010-02

15 Patches per carton

Storage: Store at 20 to 25 C (68 to 77 F)

Avoid direct sunlight

Distributed by: Alivio Medical Products, LLC

Hollywood, FL

LEVATIO PATCH menthol, capsaicin patch

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69512-010 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (MENTHOL) MENTHOL 5 g in 100 g CAPSAICIN (CAPSAICIN) CAPSAICIN .03 g in 100 g

Inactive Ingredients Ingredient Name Strength ACRYLIC ACID ALUMINUM HYDROXIDE CROSCARMELLOSE SODIUM 2-ETHYLHEXYL ACRYLATE GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLAMIDE (10000 MW) POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 TALC TARTARIC ACID TITANIUM DIOXIDE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69512-010-02 15 PATCH (PATCH) in 1 BOX contains a PATCH 1 8.5 g in 1 PATCH This package is contained within the BOX (69512-010-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2015

Labeler — Alivio Medical Products, LLC (079670828)

Revised: 03/2015 Alivio Medical Products, LLC