Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 35ec093b-60c1-12c9-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3.2 g)
Inactive Ingredients
Glycyrrhiza Uralensis Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-02-04
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

Apply proper amount to desired area(s) and massage the applied area until it's absorbed to the skin thoroughly.

Dosage and Administration

for external use only



Description

MENTHOL

Section 50565-1

keep out of reach of the children



Section 51727-6

WATER, ISOPROPYL ALCOHOL, GLYCERIN, GLYCYRRHIZA URALENSIS, CARBOMER, CAMPHOR, NaOH, CI 42090, METHYLPARABEN, CASTOR OIL

Section 51945-4

Section 55105-1

To relieve pain

Section 55106-9

MENTHOL

Structured Label Content

Indications and Usage (34067-9)

Apply proper amount to desired area(s) and massage the applied area until it's absorbed to the skin thoroughly.

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)

WATER, ISOPROPYL ALCOHOL, GLYCERIN, GLYCYRRHIZA URALENSIS, CARBOMER, CAMPHOR, NaOH, CI 42090, METHYLPARABEN, CASTOR OIL

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: 2026-02-15T11:59:27.361168 · Updated: 2026-03-14T22:59:25.623456