LEVATIO PATCH- menthol, capsaicin patch
Levatio Patch by
Drug Labeling and Warnings
Levatio Patch by is a Prescription medication manufactured, distributed, or labeled by Alivio Medical Products, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- DESCRIPTION
- INACTIVE INGREDIENT
- DESCRIPTION
- INDICATIONS & USAGE
-
WARNINGS
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
-
DOSAGE & ADMINISTRATION
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.
- STORAGE AND HANDLING
-
PATIENT PACKAGE INSERT
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LEVATIO PATCH
menthol, capsaicin patchProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: 69512-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN .03 g in 100 g Inactive Ingredients Ingredient Name Strength ACRYLIC ACID (UNII: J94PBK7X8S) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL ACRYLATE (UNII: WC487PR91H) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69512-010-02 15 in 1 BOX 1 8.5 g in 1 PATCH 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)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.