b41091b4-0dc0-4a88-8ff6-11979b3d307a

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
Purpose

Topical Analgesic

Description

Menthol 10.0%

Medication Information

Warnings

Avoid contact with eyes. For external use only.

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

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.
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)

Description

Menthol 10.0%

Package Labeling

Active Ingredient

Menthol 10.0%

Keep Out of Reach of Children.

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

Structured Label Content

Warnings

Avoid contact with eyes. For external use only.

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

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.
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)

Package Labeling (Package labeling)

Active Ingredient

Menthol 10.0%

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