Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 653a615f-1888-47bd-8d86-c436efddf384
Route
TOPICAL
Published
Effective Date 2012-12-17
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 2012-12-18
Description

Menthol 2.5%

Purpose

topical analgesic

Medication Information

Warnings and Precautions

For external use only

Purpose

topical analgesic

Description

Menthol 2.5%

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Directions
  • use only as directed
  • 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
Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Package Label

Muscle & Joint Pain Relief Gel

Active Ingredient

Menthol 2.5%

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

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

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

Ask A Doctor Before Use If You Have

redness over the affected area.

Keep Out of Reach of Children to Avoid Accidental Ingestion.

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

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
Warnings and Precautions (34071-1)

For external use only

Purpose

topical analgesic

Directions
  • use only as directed
  • 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
Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions
Package Label (Package label)

Muscle & Joint Pain Relief Gel

Active Ingredient (Active ingredient)

Menthol 2.5%

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

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

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

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

redness over the affected area.

Keep Out of Reach of Children to Avoid Accidental Ingestion. (Keep out of reach of children to avoid accidental ingestion.)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:34.787967 · Updated: 2026-03-14T22:53:23.299879