Drug Facts

Drug Facts

SPL v6

SPL

SPL Set ID d4119f84-eb60-4134-b58e-de13d9601199

Route

TOPICAL

Published

Effective Date 2013-03-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Menthol (10 g) Salicylic Acid (15 g)

Inactive Ingredients

Laureth-23 Methylparaben Mineral Oil Propylene Glycol Propylparaben Stearic Acid Stearyl Alcohol Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-03-01

Description

carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

-on wounds or damaged skin -with a heating pad - on a child under 12 years of age with arthritis-like condition

When using this product

-avoid contact with eyes and mucous membranes -do not bandage tightly

Indications and Usage

temporarily relieves minor aches and pains of muscles and joints associated with: Uses

-simple backache -arthritis -bruises -strains -sprains

Dosage and Administration

Directions

-adults and children 12 years of age and older: apply to all affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

Description

carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

Section 50565-1

. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

Section 51727-6

carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

Section 51945-4

Section 55105-1

Purpose

Topical analgesic

Section 55106-9

Active Ingredient

Menthol 10%

Menthol salicylate 15%

Structured Label Content

Indications and Usage (34067-9)

temporarily relieves minor aches and pains of muscles and joints associated with: Uses

-simple backache -arthritis -bruises -strains -sprains

Dosage and Administration (34068-7)

Directions

-adults and children 12 years of age and older: apply to all affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

-on wounds or damaged skin -with a heating pad - on a child under 12 years of age with arthritis-like condition

When using this product

-avoid contact with eyes and mucous membranes -do not bandage tightly

Section 50565-1 (50565-1)

. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children

Section 51727-6 (51727-6)

carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Topical analgesic

Section 55106-9 (55106-9)

Active Ingredient

Menthol 10%

Menthol salicylate 15%

Advanced Ingredient Data

[{"name": "LAURETH-23", "unii": "N72LMW566G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARYL ALCOHOL", "unii": "2KR89I4H1Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": " temporarily relieves minor aches and pains of muscles and joints associated with: Uses -simple backache -arthritis -bruises -strains -sprains", "34068-7": "Directions -adults and children 12 years of age and older: apply to all affected area not more than 3 to 4 times daily -children under 12 years of age: ask a doctor", "34071-1": "Warnings For external use only. Do not use -on wounds or damaged skin -with a heating pad - on a child under 12 years of age with arthritis-like condition When using this product -avoid contact with eyes and mucous membranes -do not bandage tightly", "50565-1": ". If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children", "51727-6": " carbomer, laureth-23, methylparaben, mineral oil, propylene glycol, propylparaben, stearamidoethyl diethylamine, stearic acid, stearyl alcohol, triethanomoline, water Inactive Ingredients", "55105-1": "Purpose Topical analgesic", "55106-9": "Active Ingredient Menthol 10% Menthol salicylate 15%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:42.635912 · Updated: 2026-03-14T23:01:30.191020