MENTHOL PAIN RELIEVING CREAM WITH MENTHOL 10%- menthol 10% cream cream

Menthol Pain Relieving Cream with Menthol 10% by

Drug Labeling and Warnings

Menthol Pain Relieving Cream with Menthol 10% by is a Otc medication manufactured, distributed, or labeled by ONE2ZEE LIMITED LIABILITY COMPANY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

Active Ingredient:

Menthol 10%

Purpose

• Pain relieving cream

Uses:

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

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

Warnings:

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

When using this product,

• 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:

• 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.

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

Inactive Ingredients

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:

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

Package Label

INGREDIENTS AND APPEARANCE

MENTHOL PAIN RELIEVING CREAM WITH MENTHOL 10% 
menthol 10% cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55629-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
TETRASODIUM EDTA (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITIS VINIFERA (GRAPE) SEED OIL (UNII: 930MLC8XGG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55629-018-05	141 g in 1 JAR; Type 0: Not a Combination Product	04/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	04/21/2025

Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)

Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111)