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SPL v16

SPL

SPL Set ID 3097a01b-cee5-492f-b65a-63992fb28e3a

Route

topical

Published

Effective Date 2011-05-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

salicylic acid (12 g) menthol (3 g)

Inactive Ingredients

petrolatum paraffin lanolin d&c red no. 17

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2011-04-26 Until 2021-08-31

Purpose

Topical analgesic

Description

Menthol 3% Methyl Salicylate 12%

Medication Information

Warnings

For external use only

Uses

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

Purpose

Topical 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

D&C red no. 17, lanolin, paraffin, petrolatum

Description

Menthol 3% Methyl Salicylate 12%

Section 50565-1

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Active Ingredients

Menthol 3%

Methyl Salicylate 12%

When Using This Product

avoid contact with the eyes
do not bandage tightly
do not apply to wounds or damaged skin

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

Structured Label Content

Warnings

For external use only

Uses

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

Purpose

Topical 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)

D&C red no. 17, lanolin, paraffin, petrolatum

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Active Ingredients (Active ingredients)

Menthol 3%

Methyl Salicylate 12%

When Using This Product (When using this product)

avoid contact with the eyes
do not bandage tightly
do not apply to wounds or damaged skin

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

Advanced Ingredient Data

[{"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 17", "unii": "ND733RX3JN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of minor aches and pains of muscles and joints", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Topical 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 ingredients": "Menthol 3% Methyl Salicylate 12%", "Inactive ingredients": "D&C red no. 17, lanolin, paraffin, petrolatum", "When using this product": "avoid contact with the eyes do not bandage tightly do not apply to wounds or damaged skin", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:31.514834 · Updated: 2026-03-14T23:13:05.198485