SPL v1
SPL
SPL Set ID b4c5487c-1314-4d63-96df-077e72e7ee95
Route
TOPICAL
Published
Effective Date 2025-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Ammonia Carbomer Homopolymer, Unspecified Type Cupric Sulfate Fd&c Blue No. 1 Isopropyl Alcohol Magnesium Sulfate, Unspecified Form Water Sodium Hydroxide Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-25
Description

Menthol 2%                                          Topical analgesic

Purpose

Menthol 2%                                          Topical analgesic

Medication Information

Purpose

Menthol 2%                                          Topical analgesic

Description

Menthol 2%                                          Topical analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
  • Provides cooling relief
Section 50565-1

Section 55105-1

Warnings

For external use only

Do not use:

  • With other topical pain relievers
  • With heating pads or heating devices

Stop use and ask a doctor if:

  • Condition worsens
  • Symptoms last more than 7 days and/or subside and occur again within a few days

If pregnant or breast-feeding: Ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Clean affected area before applying product
  • Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily
  • Children under 2 years of age: Ask a doctor
Product Label

Other Information
  • store at 20° - 25°C ( 68° - 77° F) [ see USP Controlled Room Temperature], in a tightly closed container
  • store in a cool place 
  • do not use, pour, spill or store near heat or open flame 
Inactive Ingredients

Ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol

Active Ingredient                                   purpose

Menthol 2%                                          Topical analgesic

Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • Arthritis
  • Simple backache
  • Strains
  • Bruises
  • Sprains
  • Provides cooling relief
Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only

Do not use:

  • With other topical pain relievers
  • With heating pads or heating devices

Stop use and ask a doctor if:

  • Condition worsens
  • Symptoms last more than 7 days and/or subside and occur again within a few days

If pregnant or breast-feeding: Ask a health professional before use.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Clean affected area before applying product
  • Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily
  • Children under 2 years of age: Ask a doctor
Product Label (Product label)

Other Information (Other information)
  • store at 20° - 25°C ( 68° - 77° F) [ see USP Controlled Room Temperature], in a tightly closed container
  • store in a cool place 
  • do not use, pour, spill or store near heat or open flame 
Inactive Ingredients

Ammonium hydroxide, carbomer, cupric sulfate, FD&C blue no. 1, isopropyl alcohol, magnesium sulfate, purified water, sodium hydroxide, thymol

Active Ingredient                                   purpose (Active Ingredient                                   Purpose)

Menthol 2%                                          Topical analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.702313 · Updated: 2026-03-14T23:09:34.496634