Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ecdb2270-d247-4fc4-92d1-f9cf78129085
Route
TOPICAL
Published
Effective Date 2012-02-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Sesame Oil Schinus Terebinthifolius Whole Zinc Oxide Methyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-01
Description

Menthol 4%

Purpose

External Analgesic

Medication Information

Purpose

External Analgesic

Dosage and Administration

Directions

Adults and children2 years of age and older. Apply to affected area not more than 3-4 times daily.

Children under 2 years of age: Do not use, consult a doctor

Description

Menthol 4%

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
Section 50565-1

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Section 51727-6

Inactive Ingredients Sesame Oil, Terebinthina resin, Zinc Oxide and Methyl salicylate

Section 51945-4
Package Label



Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Warnings
  • For external use only
  • Avoid getting into the eyes or on mucus membranes.

Active Ingredients

Menthol 4%

When Using This Product
  • do not apply to wound or damaged skin.

  • do not bandage tightly
  • do not use otherwise than as directed



Stop Use and Ask A Doctor If
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • pain persists for more than 10 days
  • redness is present
  • conditions affect children under 12 years of age

Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
Dosage and Administration (34068-7)

Directions

Adults and children2 years of age and older. Apply to affected area not more than 3-4 times daily.

Children under 2 years of age: Do not use, consult a doctor

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

Section 51727-6 (51727-6)

Inactive Ingredients Sesame Oil, Terebinthina resin, Zinc Oxide and Methyl salicylate

Section 51945-4 (51945-4)
Package Label



Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Purpose

External Analgesic

Warnings
  • For external use only
  • Avoid getting into the eyes or on mucus membranes.

Active Ingredients

Menthol 4%

When Using This Product (When using this product)
  • do not apply to wound or damaged skin.

  • do not bandage tightly
  • do not use otherwise than as directed



Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
  • pain persists for more than 10 days
  • redness is present
  • conditions affect children under 12 years of age

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:25.101220 · Updated: 2026-03-14T22:53:00.263233