drug facts

drug facts
SPL v1
SPL
SPL Set ID 4a714458-6ee7-4a97-8b2b-8b473cae92d7
Route
topical
Published
Effective Date 2010-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (2.5 g)
Inactive Ingredients
camphor (synthetic) carbomer homopolymer type c glycerin isopropyl alcohol methylparaben polysorbate 60 water trolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2010-08-27
Purpose

Topical analgesic

Description

Menthol 2.5%

Medication Information

Warnings and Precautions

For external use only

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Purpose

Topical analgesic

Directions
  • adults and children 12 years of age and older:  apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:  ask a doctor

Other Information
  • store at 20 ° to 25 ° C (68 ° to 77 ° F)
Inactive Ingredients

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

Description

Menthol 2.5%

Do Not Use
  • on wound s or damaged skin

  • with a heating pad

  • on a child under 12 years of age with arthritis-like conditions

Package Label

Muscle and joint pain relief rub

Active Ingredient

Menthol 2.5%

When Using This Product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

redness over the affected area.

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Purpose

Topical analgesic

Directions
  • adults and children 12 years of age and older:  apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:  ask a doctor

Other Information (Other information)
  • store at 20 ° to 25 ° C (68 ° to 77 ° F)
Inactive Ingredients (Inactive ingredients)

camphor, carbomer 940, glycerin, isoprophyl alcohol, methylparaben, polysorbate 60, purified water, and trolamine

Do Not Use (Do not use)
  • on wound s or damaged skin

  • with a heating pad

  • on a child under 12 years of age with arthritis-like conditions

Package Label (Package label)

Muscle and joint pain relief rub

Active Ingredient (Active ingredient)

Menthol 2.5%

When Using This Product (When using this product)
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep Out of Reach of Children (Keep out of reach of children)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

redness over the affected area.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:08.708873 · Updated: 2026-03-14T22:52:29.225907