SPL v4
SPL
SPL Set ID b22bb19a-14e5-3d32-e053-2a95a90ae520
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (25 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (55000 Cps) Propylparaben Methylparaben Polysorbate 80 Edetate Disodium Isopropyl Alcohol Propylene Glycol .alpha.-tocopherol Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-01
Description

Menthol 2.5%

Purpose

Topical analgesic

Medication Information

Purpose

Topical analgesic

Description

Menthol 2.5%

Uses

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

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains
Section 51945-4

Warnings

for external use only

Questions

www.drspharmacyusa.com

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
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
Active Ingredient

Menthol 2.5%

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

Vitamin E, Propylene glycol,Polysorbate 80,Water, Isopropyl alcohol,Carbomer interpolymer typ A, edta, Methylparaben, Propylparaben.

Ask A Doctor Before Use

Ask a doctor before use if you have redness over the affected area.

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.

Structured Label Content

Uses

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

  • simple backaches
  • arthritis
  • strains
  • bruises
  • sprains
Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

for external use only

Questions

www.drspharmacyusa.com

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
Do Not Use (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
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)

Vitamin E, Propylene glycol,Polysorbate 80,Water, Isopropyl alcohol,Carbomer interpolymer typ A, edta, Methylparaben, Propylparaben.

Ask A Doctor Before Use (Ask a doctor before use)

Ask a doctor before use if you have redness over the affected area.

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)

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)

Keep out of reach of children. 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: 2026-02-15T12:05:18.527380 · Updated: 2026-03-14T23:06:55.199519