Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID b92e7078-cdaa-4c7d-a6e4-1a8e5bb1d5e1
Route
TOPICAL
Published
Effective Date 2023-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3.0 g)
Inactive Ingredients
Aloe Benzyl Alcohol Caprylic/capric/lauric Triglyceride Carbomer Copolymer Type A Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Cetyl Alcohol Orange Oil Palmarosa Oil Water Eucalyptus Oil Glycerin Arginine Lavender Oil Hydrogenated Soybean Lecithin Dimethyl Sulfone Peppermint Oil Phenoxyethanol Potassium Hydroxide .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-05-22
Description

Menthol 3%

Purpose

Counterirritant

Medication Information

Purpose

Counterirritant

Description

Menthol 3%

Usage

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Section 51945-4

Warnings

For external use only. Avoid contact with the eyes. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again after a few days, discontinue use of this product and consult a physician.

Do Not Use

  • on wounds or damaged skin
  • when bandaged tightly or with a heating pad
  • with other topical products
Directions
  • Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily.
  • Gently massage until absorbed.
  • Children under 2 years of age: consult a physician.
Active Ingredient

Menthol 3%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Eucalyptus Globulus Leaf Oil, Glycerine, L-Arginine Monohydrochloride, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Methylsulfonylmethane, Phenoxyethanol, Potassium Hydroxide, Tocopheryl Acetate

Keep Out of Reach of Children

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

Structured Label Content

Usage (USAGE)

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Counterirritant

Warnings (WARNINGS)

For external use only. Avoid contact with the eyes. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again after a few days, discontinue use of this product and consult a physician.

Do Not Use

  • on wounds or damaged skin
  • when bandaged tightly or with a heating pad
  • with other topical products
Directions (DIRECTIONS)
  • Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily.
  • Gently massage until absorbed.
  • Children under 2 years of age: consult a physician.
Active Ingredient (ACTIVE INGREDIENT)

Menthol 3%

Inactive Ingredients (INACTIVE INGREDIENTS)

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Eucalyptus Globulus Leaf Oil, Glycerine, L-Arginine Monohydrochloride, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Methylsulfonylmethane, Phenoxyethanol, Potassium Hydroxide, Tocopheryl Acetate

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 immediately.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:06.399260 · Updated: 2026-03-14T23:01:33.532889