Refreshing External Analgesic Oil

SPL v2

SPL

SPL Set ID e2729023-d689-7ae2-e053-2a95a90a78dc

Route

TOPICAL

Published

Effective Date 2022-06-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Salicylic Acid (15 g) Menthol (14 g)

Inactive Ingredients

Clove Oil Light Mineral Oil Eucalyptus Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-06-20

Description

Menthol 14% Methyl Salicylate 15%

Purpose

Topical Analgesic Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 14% Methyl Salicylate 15%

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with ■simple backache ■strains ■bruises ■ sprains

Warning

For external use only

Question?

1-800-777-6717 or 1-800-645-0769

Directions

■ Use only as directed ■ 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: ask a doctor

Do Not Use

■ on wounds or damaged skin ■ with a heatng pad

Package Label

Active Ingredients

Menthol 14%

Methyl Salicylate 15%

Inactive Ingredients

clove oil, eucalyptus oil, fragrance, light mineral oil

When Using This Product

■ avoid contact with eyes or on mucous membranes ■ do not bandage tightly

Ask A Doctor Before Use If

you have readness over affected area

Stop Use and Ask A Doctor If

■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive skin irritation occurs

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

Structured Label Content

Uses

temporarily relieves the minor aches and pains of muscles and joints associated with ■simple backache ■strains ■bruises ■ sprains

Purpose

Topical Analgesic

Warning

For external use only

Question?

1-800-777-6717 or 1-800-645-0769

Directions

■ Use only as directed ■ 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: ask a doctor

Do Not Use (Do not use)

■ on wounds or damaged skin ■ with a heatng pad

Package Label

Active Ingredients

Menthol 14%

Methyl Salicylate 15%

Inactive Ingredients

clove oil, eucalyptus oil, fragrance, light mineral oil

When Using This Product (When using this product)

■ avoid contact with eyes or on mucous membranes ■ do not bandage tightly

Ask A Doctor Before Use If (Ask a doctor before use if)

you have readness over affected area

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

■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive skin irritation occurs

Keep Out of Reach of Children (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": "CLOVE OIL", "unii": "578389D6D0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIGHT MINERAL OIL", "unii": "N6K5787QVP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "14", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves the minor aches and pains of muscles and joints associated with ■simple backache ■strains ■bruises ■ sprains", "Purpose": "Topical Analgesic Topical Analgesic", "Warning": "For external use only", "Question?": "1-800-777-6717 or 1-800-645-0769", "Directions": "■ Use only as directed ■ 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: ask a doctor", "Do not use": "■ on wounds or damaged skin ■ with a heatng pad", "Active Ingredients": "Menthol 14% Methyl Salicylate 15%", "Inactive Ingredients": "clove oil, eucalyptus oil, fragrance, light mineral oil", "When using this product": "■ avoid contact with eyes or on mucous membranes ■ do not bandage tightly", "Ask a doctor before use if": "you have readness over affected area", "Stop use and ask a doctor if": "■ condition worsens, or symptoms persist for more than 7 days ■ symptoms clear up and occur again within a few days ■ excessive skin irritation occurs", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.895963 · Updated: 2026-03-14T23:03:52.479021