TheraCare 4% Lidocaine and 1% Menthol Cream

Manufacturer
Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2024-05-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:49

Label at a glance#

ProductTheraCare 4% Lidocaine and 1% Menthol Cream
Active ingredientLIDOCAINE, MENTHOL
Label structure7 sections

Dosage and administration

adults and children over 12 years: ■ apply a thin layer to affected area, not more than 6 to 8 hours, not exceed 3 applications in a 24 hour period. children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL

Menthol

Purposes

OTC - PURPOSE SECTION

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Menthol 1%.......................................................................................................................................Topical analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

■ on large areas of the body or on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

When using this product

OTC - WHEN USING SECTION

■ use only as directed. Read and follow all directions and warnings on this carton.

■ do not allow contact with the eyes

■ do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ condition worsens

■ symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

■ apply a thin layer to affected area, not more than 6 to 8 hours, not exceed 3 applications in a 24 hour period.

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer Type A, Cyclopentasiloxane 5, Dihexadecyl phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, edetate disodium, Ethylhexylglycerin, Glyceryl monostearate, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, Steareth-21, Water

PRINCIPAL DISPLAY PANEL TheraCare 4% Lidocaine & 1% Menthol Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-931-01TheraCare 4% Lidocaine and 1% Menthol Cream1 in 1 CARTONCREAM13
71101-931-01TheraCare 4% Lidocaine and 1% Menthol Cream49.6 g in 1 BOTTLECREAM49.63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-931THERACARE 4% LIDOCAINE AND 1% MENTHOL CREAM (MENTHOL AND LIDOCAINE) CREAM [VERIDIAN HEALTHCARE]3Current NDC, Legacy NDC, 2 package rows20240522_c80ba251-91a5-0858-e053-2995a90a9cff.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-93171101-931-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
TheraCare 4% Lidocaine and 1% Menthol CreamMENTHOL AND LIDOCAINEVeridian Healthcarec80ba251-91a5-0858-e053-2995a90a9cff2024-05-21WarningsExact identifier
ndc (package): 71101-931-01
ndc (product): 71101-931
ndc11 (package): 71101093101
spl id: 18fad642-24ee-746c-e063-6294a90ae791
spl set id: c80ba251-91a5-0858-e053-2995a90a9cff

Reported adverse events (FAERS/openFDA)#

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