Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID e6a58a3e-8c6f-4dc0-ae5d-08a40f20ac27

Route

TOPICAL

Published

Effective Date 2013-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Camphor (synthetic) (3 g) Menthol (10 g) Salicylic Acid

Inactive Ingredients

Alcohol Eucalyptus Oil Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-12-30

Description

Camphor 3% Menthol 10% Methyl Salicylate 10%

Purpose

External analgesic External analgesic External analgesic

Medication Information

Purpose

External analgesic

Description

Camphor 3% Menthol 10% Methyl Salicylate 10%

Uses

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

■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

■ For external use only

■ Avoid getting into the eyes or on mucous membranes

■ Discontinue use if excessive irritation of the skin develops

Directions

■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily

■ Apply liberally and gently rub into affected area

■ Children under 12 years of age, consult a doctor before using

■ Do not use otherwise than as directed

Package Label

Active Ingredients

Camphor 3%

Menthol 10%

Methyl Salicylate 10%

Inactive Ingredients

Alcohol, Eucalyptus oil, Glycerol, Water

When Using This Product

■ Do not apply to wound or damaged skin.

■ Do not bandage tightly

Stop Use and Ask A Doctor If

■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

■ Pain persists for more than 10 days conditions

■ redness is present

■ Conditions affect children under 12 years of age

Keep Out of Reach of Children

to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away.

Structured Label Content

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

■ Avoid getting into the eyes or on mucous membranes

■ Discontinue use if excessive irritation of the skin develops

Directions

■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily

■ Apply liberally and gently rub into affected area

■ Children under 12 years of age, consult a doctor before using

■ Do not use otherwise than as directed

Package Label

Active Ingredients

Camphor 3%

Menthol 10%

Methyl Salicylate 10%

Inactive Ingredients (Inactive ingredients)

Alcohol, Eucalyptus oil, Glycerol, Water

When Using This Product (When using this product)

■ Do not apply to wound or damaged skin.

■ Do not bandage tightly

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

■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

■ Pain persists for more than 10 days conditions

■ redness is present

■ Conditions affect children under 12 years of age

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

to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away.

Advanced Ingredient Data

[{"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 External analgesic External analgesic", "Warnings": "■ For external use only ■ Avoid getting into the eyes or on mucous membranes ■ Discontinue use if excessive irritation of the skin develops", "Directions": "■ Adults and children 12 years of age and older apply to affected area not more than 3 to 4 time daily ■ Apply liberally and gently rub into affected area ■ Children under 12 years of age, consult a doctor before using ■ Do not use otherwise than as directed", "Active Ingredients": "Camphor 3% Menthol 10% Methyl Salicylate 10%", "Inactive ingredients": "Alcohol, Eucalyptus oil, Glycerol, Water", "When using this product": "■ Do not apply to wound or damaged skin. ■ Do not bandage tightly", "Stop use and ask a doctor if": "■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ Pain persists for more than 10 days conditions ■ redness is present ■ Conditions affect children under 12 years of age", "Keep out of reach of children": "to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:43.935365 · Updated: 2026-03-14T22:53:39.434183