Storage and handling
Store at room temperature. Avoid direct sunlight.
Levatio Patch
- Manufacturer
- Alivio Medical Products, LLC
- Effective date
- 2015-03-02
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:20:22
Label at a glance#
ProductLevatio Patch
Active ingredientMENTHOL, CAPSAICIN
Label structure9 sections
Label contents#
Full prescribing information#
DESCRIPTION SECTION
Active Ingredient
Menthol 5.00 %
Capsaicin 0.03 %
INACTIVE INGREDIENT SECTION
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)
DESCRIPTION SECTION
Purpose
External Analgesic
External Analgesic
INDICATIONS & USAGE SECTION
Uses:
For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains,
bruises and sprains
WARNINGS SECTION
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 SECTION
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 SECTION
Store at room temperature. Avoid direct sunlight.
SPL PATIENT PACKAGE INSERT SECTION
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69512-010-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-029b-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69512-010-02 | Levatio Patch | 15 in 1 BOX | PATCH | 15 | 1 | |
| 69512-010-02 | Levatio Patch | 8.5 g in 1 PATCH | PATCH | 8.5 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69512-010-02 | EA - Each | 69512-010 | 01d09a6d-fdcc-4434-a857-48fbf26fc7dc | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CAPSAICIN | ACTIVE INGREDIENT | S07O44R1ZM | 1 | |
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| CAPSAICIN | ACTIVE MOIETY | S07O44R1ZM | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| 2-ETHYLHEXYL ACRYLATE | INACTIVE INGREDIENT | HR49R9S6XG | 1 | |
| ACRYLIC ACID | INACTIVE INGREDIENT | J94PBK7X8S | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| METHYL ACRYLATE | INACTIVE INGREDIENT | WC487PR91H | 1 | |
| NONOXYNOL-30 | INACTIVE INGREDIENT | JJX07DG188 | 1 | |
| POLYACRYLAMIDE (10000 MW) | INACTIVE INGREDIENT | E2KR9C9V2I | 1 | |
| POLYACRYLIC ACID (250000 MW) | INACTIVE INGREDIENT | 9G2MAD7J6W | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Levatio Patch
- Menthol, Capsaicin
- MENTHOL
- CAPSAICIN
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69512-010 | 69512-010-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 5 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FILM COATED / ORAL | 91 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 18 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / OPHTHALMIC | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | GRANULE / ORAL | 150 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET / BUCCAL | 15 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | TABLET, ORALLY DISINTEGRATING / ORAL | 45 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, EXTENDED RELEASE / ORAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / SUBLINGUAL | 10 mg | ||
| TALC | TALC | 7SEV7J4R1U | POWDER, FOR SUSPENSION / ORAL | 735 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAMUSCULAR | 4 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | GRANULE, DELAYED RELEASE / ORAL | 525 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET / ORAL | 736 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / RECTAL | 315 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE / ORAL | 729 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, SPRAY / TOPICAL | 6.89 %w/w | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION, SOLUTION / INTRAMUSCULAR | 18 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, EXTENDED RELEASE / ORAL | 53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / TOPICAL | 20 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / VAGINAL | 28 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION / INTRAVENOUS | 20 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | OINTMENT / TOPICAL | 5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED / ORAL | 24 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 87ad427f-aa3f-4814-88ac-f546efdf7078 | e00ce082-5d08-4628-9b99-87ecd2ac43a6 | 2015-03-02 | Warnings | 87ad427f-aa3f-4814-88ac-f546efdf7078 e00ce082-5d08-4628-9b99-87ecd2ac43a6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.