Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 35fbc9b0-e46a-5717-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Water Glycerin Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Completed Since 2016-02-04 Until 2016-08-09
Description

MENTHOL

Medication Information

Warnings and Precautions
  • Under normal room conditions, the shelf life is estimated at 2 years.
  • Recommended Use: Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, sprains.
  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Rub in thoroughly until gel is absorbed.
  • Use with caution on sensitive areas.
  • It is recommended that you do a patch test before applying liberally to the skin.
Indications and Usage

Spray proper amount to treatment area(s)

Dosage and Administration

for external use only



Description

MENTHOL

Section 50565-1

keep out of reach of the children



Section 51727-6

ALCOHOL, WATER, GLYCERIN, EUCALYPTUS GLOBULUS LEAF OIL, GLYCYRRHIZA (LICORICE) ROOT EXTRACT, BOSWELLIA SERRATA GUM EXTRACT, ALLANTOIN

Section 51945-4

Section 55105-1

To relieve pain

Section 55106-9

MENTHOL

Structured Label Content

Indications and Usage (34067-9)

Spray proper amount to treatment area(s)

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)
  • Under normal room conditions, the shelf life is estimated at 2 years.
  • Recommended Use: Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, arthritis, strains, bruises, sprains.
  • Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.
  • Rub in thoroughly until gel is absorbed.
  • Use with caution on sensitive areas.
  • It is recommended that you do a patch test before applying liberally to the skin.
Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

ALCOHOL, WATER, GLYCERIN, EUCALYPTUS GLOBULUS LEAF OIL, GLYCYRRHIZA (LICORICE) ROOT EXTRACT, BOSWELLIA SERRATA GUM EXTRACT, ALLANTOIN

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

To relieve pain

Section 55106-9 (55106-9)

MENTHOL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:27.365343 · Updated: 2026-03-14T22:59:25.623456