FDA.reportPublic FDA data

Menthol Pain Relieving Cream with Menthol 10%

Manufacturer
ONE2ZEE LIMITED LIABILITY COMPANY
Effective date
2025-05-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:00:28

Label at a glance#

ProductMenthol Pain Relieving Cream with Menthol 10%
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: simple  backache  arthritis  strains bruises  sprains

Dosage and administration

adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily  children under 12 years of age: consult a physician  wash hands after use with cool water Adults and children 12 years and older : For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cl...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Purpose

OTC - PURPOSE SECTION

  • Pain relieving cream

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple 
  • backache 
  • arthritis 
  • strains
  • bruises 
  • sprains

Warnings:

WARNINGS SECTION

  • For external use only. If condition worsens or does not improve within 7 days, consult a doctor.

When using this product,

OTC - WHEN USING SECTION

  • use only as directed 
  • avoid contact with the eyes or on mucous membranes 
  • do not apply to wounds or damaged skin 
  • do not apply to irritated skin or if excessive irritation develops 
  • do not bandage tightly or use with heating pad or device

Directions:

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily 
  • children under 12 years of age: consult a physician 
  • wash hands after use with cool water

Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a clean, soft cloth before application of this product. Apply externally up to 6 times per day.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

Other Information:

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F)  store in a cool dry place away from direct sunlight

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar5ozabelJar5ozabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
253020menthol 10 % Topical CreamPSN2
253020menthol 100 MG/ML Topical CreamSCD2
253020menthol 10 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55629-018-05Menthol Pain Relieving Cream with Menthol 10%141 g in 1 JARCREAM1412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55629-018MENTHOL PAIN RELIEVING CREAM WITH MENTHOL 10% (MENTHOL 10% CREAM) CREAM [ONE2ZEE LIMITED LIABILITY COMPANY]2Current NDC, 1 package rows20250507_ae09e93f-3988-4477-ae53-b2f3df9769fb.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55629-01855629-018-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DIMETHICONE92RU3N3Y1OIACT
GLUCONOLACTONEWQ29KQ9POTIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT
POLYSORBATE 60CAL22UVI4MIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
TETRASODIUM EDTAMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITIS VINIFERA (GRAPE) SEED OIL930MLC8XGGIACT

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
Menthol Pain Relieving Cream with Menthol 10%MENTHOL 10% CREAMONE2ZEE LIMITED LIABILITY COMPANYae09e93f-3988-4477-ae53-b2f3df9769fb2025-05-05WarningsExact identifier
ndc (package): 55629-018-05
ndc (product): 55629-018
ndc11 (package): 55629001805
spl id: b3126f77-144f-47d0-9a8b-b8b840f96bdc
spl set id: ae09e93f-3988-4477-ae53-b2f3df9769fb

Reported adverse events (FAERS/openFDA)#

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