drug facts

drug facts
SPL v2
SPL
SPL Set ID 85814fff-35f8-447f-b669-87eaf55e9859
Route
topical
Published
Effective Date 2014-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.5 g)
Inactive Ingredients
aloe caprylic/capric/lauric triglyceride carbomer copolymer type a polyoxyl 20 cetostearyl ether cetostearyl alcohol cetyl alcohol orange oil palmarosa oil diazolidinyl urea water eucalyptus oil glycerin arginine lavender oil hydrogenated soybean lecithin dimethyl sulfone peppermint oil tocopherol .alpha.-tocopherol acetate trolamine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2004-05-22
Purpose

Counterirritant

Description

Menthol 2.5%

Medication Information

Warnings

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

Do Not Use

  • on wounds or damaged skin
  • when bandaged tightly
  • with other topical products
Purpose

Counterirritant

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 doctor.
Inactive Ingredients

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

Description

Menthol 2.5%

Usage

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

Section 51945-4

Active Ingredient

Menthol 2.5%

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

Warnings (WARNINGS)

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

Do Not Use

  • on wounds or damaged skin
  • when bandaged tightly
  • with other topical products
Purpose (PURPOSE)

Counterirritant

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 doctor.
Inactive Ingredients (INACTIVE INGREDIENTS)

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

Usage (USAGE)

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

Section 51945-4 (51945-4)

Active Ingredient (ACTIVE INGREDIENT)

Menthol 2.5%

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

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Source: dailymed · Ingested: 2026-02-15T12:08:14.727083 · Updated: 2026-03-14T23:12:25.780176