Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 96c97f28-ef22-4554-8a9e-0447c427e909
Route
TOPICAL
Published
Effective Date 2014-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.0 g)
Inactive Ingredients
Water Isopropyl Alcohol Carbomer Homopolymer Type C Thymol Ammonia Sodium Hydroxide Magnesium Sulfate Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-10-06
Description

Menthol 2.0%

Purpose

Analgesic.

Medication Information

Purpose
  • Analgesic.
Description

Menthol 2.0%

Uses

  • Temporary relief of minor aches and pains in: muscles and joints.
Section 51945-4

Warnings
  • For external use only.
  • Avoid contact with eyes and mucus membranes.

When using this product, do not:

  • use with heating pads or heating devices
  • use, pour, spill or store near open flame
  • use with other creams, sprays or liniments
  • apply to damaged skin or wounds
  • bandage area tightly

To do so may result in excessive skin irritation or skin burn.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If you have sensitive skin consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before using this product.

Directions

Directions:

  • See important warnings under ''When Using This Product''.
  • Do not apply to children under 2 years of age, unless advised by a physician.
  • Adults and children over 2 years of age and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily.
Active Ingredient



Menthol 2.0%

Inactive Ingredients

INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, CARBOMER, THYMOL, AMMONIUM HYDROXIDE, SODIUM HYDROXIDE, MAGNESIUM SULFATE, FD&C BLUE 1.

Keep Out of Reach of Children
  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

  • Temporary relief of minor aches and pains in: muscles and joints.
Section 51945-4 (51945-4)

Purpose
  • Analgesic.
Warnings
  • For external use only.
  • Avoid contact with eyes and mucus membranes.

When using this product, do not:

  • use with heating pads or heating devices
  • use, pour, spill or store near open flame
  • use with other creams, sprays or liniments
  • apply to damaged skin or wounds
  • bandage area tightly

To do so may result in excessive skin irritation or skin burn.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If you have sensitive skin consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before using this product.

Directions

Directions:

  • See important warnings under ''When Using This Product''.
  • Do not apply to children under 2 years of age, unless advised by a physician.
  • Adults and children over 2 years of age and older: Apply liberally to painful area and massage until gel is absorbed into skin. Repeat no more than 3-4 times daily.
Active Ingredient



Menthol 2.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, CARBOMER, THYMOL, AMMONIUM HYDROXIDE, SODIUM HYDROXIDE, MAGNESIUM SULFATE, FD&C BLUE 1.

Keep Out of Reach of Children (Keep out of reach of children)
  • In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:50.518392 · Updated: 2026-03-14T22:53:51.342349