SPL v6
SPL
SPL Set ID b41091b4-0dc0-4a88-8ff6-11979b3d307a
Route
TOPICAL
Published
Effective Date 2017-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (100 mg)
Inactive Ingredients
Dimethyl Sulfone Eucalyptus Oil Glucosamine Sulfate Hydroxypropyl Cellulose, Unspecified Peg-8 Dimethicone Pentylene Glycol Peppermint Oil Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-19
Description

Menthol 10.0%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 10.0%

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Warnings

Avoid contact with eyes. For external use only.

Directions

Adults and children over 12 years:

ask a doctor. Children 12 years or younger:

  • apply directly onto affected area without the need to bandage
  •  repeat if necessary, but do not apply more than 4 times daily.
Package Labeling

Active Ingredient

Menthol 10.0%

Inactive Ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP)

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical Analgesic

Warnings

Avoid contact with eyes. For external use only.

Directions

Adults and children over 12 years:

ask a doctor. Children 12 years or younger:

  • apply directly onto affected area without the need to bandage
  •  repeat if necessary, but do not apply more than 4 times daily.
Package Labeling (Package labeling)

Active Ingredient

Menthol 10.0%

Inactive Ingredients

acrylic acid/vinyl ester copolymer, dimethylsulfone (MSM), eucalyptus oil, glucosamine sulfate, hydroxypropylcellulose, SD alcohol 39C, PEG-8 dimethicone, pentylene glycol, peppermint oil, triethanolamine, water (USP)

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:42.618724 · Updated: 2026-03-14T23:01:30.191020