Drug Facts

Drug Facts
SPL v33026
SPL
SPL Set ID 2c9d070c-bf90-4482-8a6e-c7491cdd34c5
Route
TOPICAL
Published
Effective Date 2025-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (12 g) Salicylic Acid (19.5 g)
Inactive Ingredients
White Petrolatum Eucalyptus Oil Lanolin Oil Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-01
Description

Menthol- 16% Methyl Salicylate- 26%

Medication Information

Description

Menthol- 16% Methyl Salicylate- 26%

Uses

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

  • Simple backache
  • Sprains
  • Bruises
  • Arthritis
Package

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily, children under 2 years of age: Do not use, consult a doctor
Do Not Use
  • On wounds
  • On the face
  • Damaged or irritated skin
  • Otherwise than as directed
Other Information

Keep bottle tightly closed, store in a cool place

If swallowed, get medical help or contact poison control center immediately 

Active Ingredients

Menthol- 16%

Methyl Salicylate- 26%

Inactive Ingredients

White Petrolatum, Eucalyptus Oil, Lanolin Oil, Paraffin

When Using This Product
  • Avoid contact with the eyes, mouth or mucous membranes
  • Do not bandage tightly
Stop Using and Consult With Doctor If:
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Use with caution if you are allergic to ingredients
Keep Out of Reach of Children to Avoid Accidental Poisoning

Structured Label Content

Uses

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

  • Simple backache
  • Sprains
  • Bruises
  • Arthritis
Package

Warnings

For external use only

Directions
  • Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily, children under 2 years of age: Do not use, consult a doctor
Do Not Use (Do not use)
  • On wounds
  • On the face
  • Damaged or irritated skin
  • Otherwise than as directed
Other Information

Keep bottle tightly closed, store in a cool place

If swallowed, get medical help or contact poison control center immediately 

Active Ingredients

Menthol- 16%

Methyl Salicylate- 26%

Inactive Ingredients

White Petrolatum, Eucalyptus Oil, Lanolin Oil, Paraffin

When Using This Product (When using this product)
  • Avoid contact with the eyes, mouth or mucous membranes
  • Do not bandage tightly
Stop Using and Consult With Doctor If: (Stop using and consult with doctor if:)
  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Use with caution if you are allergic to ingredients
Keep Out of Reach of Children to Avoid Accidental Poisoning (Keep out of reach of children to avoid accidental poisoning)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:55.647944 · Updated: 2026-03-14T23:11:54.825001