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.
Active Ingredient

MENTHOL

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

Structured Label Content

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.
Active Ingredient (55106-9)

MENTHOL

Indications and Usage (34067-9)

Spray proper amount to treatment area(s)

Dosage and Administration (34068-7)

for external use only



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

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