Menthol Pain Relieving Cream - Menthol 10%

Menthol Pain Relieving Cream - Menthol 10%
SPL v2
SPL
SPL Set ID ae09e93f-3988-4477-ae53-b2f3df9769fb
Route
TOPICAL
Published
Effective Date 2025-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.1 g)
Inactive Ingredients
Cetostearyl Alcohol Diazolidinyl Urea Dimethicone Gluconolactone Sodium Benzoate Glycerin Glyceryl Monostearate Ilex Paraguariensis Leaf Medium-chain Triglycerides Water Polysorbate 60 Sodium Hydroxide Sodium Stearoyl Lactylate Tetrasodium Edta .alpha.-tocopherol Acetate Vitis Vinifera (grape) Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-21

Description

Menthol 10%

Purpose

Pain relieving cream


Medication Information

Purpose
  • Pain relieving cream
Description

Menthol 10%

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.
Drug Facts:

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.

Package Label

Active Ingredient:

Menthol 10%

Other Information:

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

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

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
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.


Structured Label Content

Uses:

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

  • simple 
  • backache 
  • arthritis 
  • strains
  • bruises 
  • sprains
Purpose
  • Pain relieving cream
Warnings:
  • For external use only. If condition worsens or does not improve within 7 days, consult a doctor.
Drug Facts: (DRUG FACTS:)

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.

Package Label

Active Ingredient:

Menthol 10%

Other Information:

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

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

When Using This Product, (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
Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

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