LevigoLT

Manufacturer
Topicare Management, LLC
Effective date
2017-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:50:03

Label at a glance#

ProductLevigoLT
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure14 sections

Dosage and administration

Distributed by: Topicare Therapeutics, LLC. 1925 Longmire Rd. Building 2, Conroe, TX 77304 Made in U.S.A. of U.S. and imported materials

Storage and handling

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from freezing.

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

LevigoLT is a Lidocaine HCI 4% and Menthol 1% topical anesthetic and analgesic cream indicated to temporarily relieve minor pain.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Each gram of LevigoLT contains:

Lidocaine HCI 4% (40mg) Topical Anesthetic

Menthol 1% (10mg) Topical Analgesic

Purpose

OTC - PURPOSE SECTION

Temporarily relieves minor pain associated with: arthritis, simple backache, sprains, bruises, muscles soreness, cramps

Warnings

WARNINGS SECTION

For external use only. Do not use on large areas of the body or on cut, irritated or swollen skin, puncture wounds, or for more than one week without consulting a doctor.

When Using This Product

OTC - WHEN USING SECTION

When using this product use only as directed. Read and follow all directions and warnings on this carton. *was hands with soap and water after applying *rare cases of serious burns have been reported with product of this type *do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated patch *avoid contact with eyes and mucous membranes *atransient burning sensation may occur upon application but generally disappears in several days

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if *condition worsens *redness is present * irritation develops *symptoms persist more than 7 days or clear up and occur again within a few days *you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Pregnancy or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poinson Control Center right away.

Indications & Usage

INDICATIONS & USAGE SECTION

Directions: Adults and children over 12 year: *apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period *after applying, wash hands with soap and water *children 12 years or younger: ask a doctor.

Questions or Comments

OTC - QUESTIONS SECTION

For questions or comments, call 1-800-635-3696.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Distributed by: Topicare Therapeutics, LLC. 1925 Longmire Rd. Building 2, Conroe, TX 77304

Made in U.S.A. of U.S. and imported materials

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Alcohol, Glycerin, Polysorbate 20, Dimethicone/Vinyl Dimethicone Crosspolymer, C12-13 Pareth-23, C12-13 Pareth-3, Cetearyl alcohol, Ceteth-10 phosphate, Dicetyl phosphate, Glyceryl Stearate, Caprylhydroxamic acid, 1,2-Hexanediol, Propanediol, Aloe Barbadensis Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Edetate Disodium

Storage and Handling

STORAGE AND HANDLING SECTION

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Protect from freezing.

Package Label. Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LevigoLTLevigoLT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN1
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD1
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70112-150-012020-01-31C16284748780-19d75b9d0-2953-f424-e053-dadaa90a57ce505c6f72-1b24-6236-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70112-150-01LevigoLT76.5 g in 1 TUBECREAM76.51
70112-150-01LevigoLT1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70112-150LEVIGOLT (LIDOCAINE/MENTHOL CREAM) CREAM [TOPICARE MANAGEMENT, LLC]1Legacy NDC, 2 package rows20170606_505c6f72-1b24-6236-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70112-150-01GM - Gram70112-150eb434626-553c-4105-9927-0cdeffcaf51412017-08-11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70112-15070112-150-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
505c6f72-1b25-6236-e054-00144ff8d46c505c6f72-1b24-6236-e054-00144ff8d46c2017-05-25WarningsExact identifier
spl id: 505c6f72-1b25-6236-e054-00144ff8d46c
spl set id: 505c6f72-1b24-6236-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.