sana sana menthol external analgesic

SPL v3

SPL

SPL Set ID 8b7edd51-e08a-4e01-9df0-8305ce17b418

Route

topical

Published

Effective Date 2025-07-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

menthol (150 mg)

Inactive Ingredients

water glycerin trolamine carboxypolymethylene

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2018-06-22

Purpose

External Analgesic

Description

Menthol 15%

Medication Information

Warnings

For external use only

Uses

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

• simple backache

• arthritis

• strains

• bruises

• sprains

Purpose

External Analgesic

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

• children under 2 years of age: consult a doctor

Inactive Ingredients

ionized water, glycerin, triethanolamine, carbopol

Description

Menthol 15%

Drug Facts

Active Ingredient

Menthol 15%

Package Labeling:

When Using This Product

• avoid contact with eyes

• do not apply to wounds or damaged skin

• do not bandage tightly

Stop Use and Ask A Doctor If

• condition worsens

• symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only

Uses

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

• simple backache

• arthritis

• strains

• bruises

• sprains

Purpose

External Analgesic

Directions

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily

• children under 2 years of age: consult a doctor

Inactive Ingredients (Inactive ingredients)

ionized water, glycerin, triethanolamine, carbopol

Drug Facts

Active Ingredient (Active ingredient)

Menthol 15%

Package Labeling:

When Using This Product (When using this product)

• avoid contact with eyes

• do not apply to wounds or damaged skin

• do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• condition worsens

• symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYPOLYMETHYLENE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "150", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains", "Purpose": "External Analgesic", "Warnings": "For external use only", "Directions": "• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: consult a doctor", "Active ingredient": "Menthol 15%", "Inactive ingredients": "ionized water, glycerin, triethanolamine, carbopol", "When using this product": "• avoid contact with eyes • do not apply to wounds or damaged skin • do not bandage tightly", "Stop use and ask a doctor if": "• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:37.873311 · Updated: 2026-03-14T23:09:29.869893