Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 0f646876-69d0-49db-ade2-2b3eb26dd399
Route
TOPICAL
Published
Effective Date 2021-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (100 mg)
Inactive Ingredients
Medium-chain Triglycerides Cetostearyl Alcohol Dimethicone Edetate Disodium Ethylhexylglycerin Gluconolactone Glycerin Glyceryl Monostearate Ilex Paraguariensis Leaf Phenoxyethanol Polysorbate 60 Sodium Hydroxide .alpha.-tocopherol Acetate Grape Seed Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-22
Description

Menthol 10%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 10%

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with:

  • arthritis
  • backache
  • strains
  • sprains
Section 50565-1

Keep out of reach of children and pets:If accidentally ingested, get medical help or contact a Poison Control Center immediately

Section 50569-3

Ask a doctor before use if you have: Sensitive skin

Flammable:Keep away from excessive heat or open flame.

Warnings:

For external use only

Directions:

Adults and Children 12 years of age and older:

  • Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 12 years of age: Consult physician
Active Ingredient

Menthol 10%

Inactive Ingredients:

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguarensis Leaf Extract, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Oil, Water.

When Using This Product:
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device
  • Store in a cool dry place, away from sunlight
If Pregnant Or Breastfeeding:

Ask a health professional before use.

Stop Use and Ask A Doctor If:
  • Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur
Principal Display Panel – 113.3 G Tube Label

cvs

Health ®

Compare to the active ingredient in Biofreeze ®Pain Relieving Foot Cream*

Pain Relieving Foot Cream

MENTHOL 10%

  • Temporarily relieves painful, achy feet
  • Soothes aggravated nerves

NET WT 4 OZ (113.3 g)

Structured Label Content

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with:

  • arthritis
  • backache
  • strains
  • sprains
Section 50565-1 (50565-1)

Keep out of reach of children and pets:If accidentally ingested, get medical help or contact a Poison Control Center immediately

Section 50569-3 (50569-3)

Ask a doctor before use if you have: Sensitive skin

Flammable:Keep away from excessive heat or open flame.

Purpose

Topical Analgesic

Warnings:

For external use only

Directions:

Adults and Children 12 years of age and older:

  • Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 12 years of age: Consult physician
Active Ingredient (Active ingredient)

Menthol 10%

Inactive Ingredients:

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguarensis Leaf Extract, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Oil, Water.

When Using This Product: (When using this product:)
  • Avoid contact with the eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device
  • Store in a cool dry place, away from sunlight
If Pregnant Or Breastfeeding: (If pregnant or breastfeeding:)

Ask a health professional before use.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)
  • Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur
Principal Display Panel – 113.3 G Tube Label (Principal Display Panel – 113.3 g Tube Label)

cvs

Health ®

Compare to the active ingredient in Biofreeze ®Pain Relieving Foot Cream*

Pain Relieving Foot Cream

MENTHOL 10%

  • Temporarily relieves painful, achy feet
  • Soothes aggravated nerves

NET WT 4 OZ (113.3 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.234730 · Updated: 2026-03-14T23:03:51.620726