SPL v2
SPL
SPL Set ID 205b0fef-4f00-db2e-e063-6294a90a93b8
Route
TOPICAL
Published
Effective Date 2024-08-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (12.5 mg)
Inactive Ingredients
Cetostearyl Alcohol Phenoxyethanol Spearmint Isopropyl Myristate Cetyl Alcohol Anhydrous Citric Acid Oregano Petrolatum Shea Butter Polyoxyl 20 Cetostearyl Ether Lanolin Mineral Oil Water Rosemary Dimethicone Ethylhexylglycerin Corn Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01 Until 2026-06-30
Description

Menthol 1.25%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Menthol 1.25%

Uses

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

  • Simple backache
  • Arthritis
  • Strains
  • Bruises
  • Sprains
Warnings

For external use only.

Directions
  • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: Do not use, consult a doctor.
Other Information

You may report serious side effects to: Dorrington LLC, 7 Skyline Dr., Suite 350, Hawthorne, NY 10532

Product Packaging

Active Ingredients

Menthol 1.25%

Inactive Ingredients

butyrospermum parkii (shea) butter, ceteareth-20, cetearyl alcohol, cetyl alcohol, citric acid, dimethicone, ethylhexlglycerin, isopropyl myristate, lanolin, mentha spicata leaf, origanum vulgare leaf extract, paraffinum liquidum, petrolatum, phenoxyethanol, purified water, rosmarinus officinalis leaf extract, zea mays oil

When Using This Product
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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

For external use only.

Directions
  • adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • children under 2 years of age: Do not use, consult a doctor.
Other Information (Other information)

You may report serious side effects to: Dorrington LLC, 7 Skyline Dr., Suite 350, Hawthorne, NY 10532

Product Packaging

Active Ingredients (Active ingredients)

Menthol 1.25%

Inactive Ingredients (Inactive ingredients)

butyrospermum parkii (shea) butter, ceteareth-20, cetearyl alcohol, cetyl alcohol, citric acid, dimethicone, ethylhexlglycerin, isopropyl myristate, lanolin, mentha spicata leaf, origanum vulgare leaf extract, paraffinum liquidum, petrolatum, phenoxyethanol, purified water, rosmarinus officinalis leaf extract, zea mays oil

When Using This Product (When using this product)
  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
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: 2026-02-15T12:07:45.104356 · Updated: 2026-03-14T23:11:30.674942