Eagle Brand Medicated Oil Rollon

SPL v3

SPL

SPL Set ID da3358ae-8679-6045-e053-2a95a90a50e3

Route

TOPICAL

Published

Effective Date 2022-03-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (14.5 g) Salicylic Acid (30 g)

Inactive Ingredients

Alcohol Mineral Oil Rose Oil Chlorophyll

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-03-04

Description

Menthol 14.5% Methyl Salicylate 30%

Purpose

Topical Analgesic Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 14.5% Methyl Salicylate 30%

Uses

temporarily relieves the minor aches and pains of muscle and joint associated with : ■simple backache ■ strains ■ bruises ■ sprains

Warning

For external use only

Question?

1-800-777-6717 or 1-800-645-0789

Directions

■ Use only as directed ■ adults and children 2 years and older: apply to affected area not more than 3 to 4 time daily. ■ children under 2 years of age: ask a doctor

Do Not Use

■ on woulds or damaged skin ■ with a heating pad

Package Label

8ml NDC: 43405-005-08

Active Ingredients

Menthol 14.5%

Methyl Salicylate 30%

Inactive Ingredients

Chlorophyll, ethyl alcohol, mineral oil, rose oil

When Using This Product

■ avoid contact with eyes or mucous membranes

■ do not bandage tightly

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 This Drug 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 muscle and joint associated with : ■simple backache ■ strains ■ bruises ■ sprains

Purpose

Topical Analgesic

Warning

For external use only

Question?

1-800-777-6717 or 1-800-645-0789

Directions

■ Use only as directed ■ adults and children 2 years and older: apply to affected area not more than 3 to 4 time daily. ■ children under 2 years of age: ask a doctor

Do Not Use (Do not use)

■ on woulds or damaged skin ■ with a heating pad

Package Label

8ml NDC: 43405-005-08

Active Ingredients

Menthol 14.5%

Methyl Salicylate 30%

Inactive Ingredients (Inactive ingredients)

Chlorophyll, ethyl alcohol, mineral oil, rose oil

When Using This Product (When using this product)

■ avoid contact with eyes or mucous membranes

■ do not bandage tightly

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 This Drug Out of Reach of Children (Keep this drug 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": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSE OIL", "unii": "WUB68Y35M7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "14.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "CHLOROPHYLL", "unii": "00WNZ48OR9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves the minor aches and pains of muscle and joint associated with : ■ simple backache ■ strains ■ bruises ■ sprains", "Purpose": "Topical Analgesic Topical Analgesic", "Warning": "For external use only", "Question?": "1-800-777-6717 or 1-800-645-0789", "Directions": "■ Use only as directed ■ adults and children 2 years and older: apply to affected area not more than 3 to 4 time daily. ■ children under 2 years of age: ask a doctor", "Do not use": "■ on woulds or damaged skin ■ with a heating pad", "Package Label": "8ml NDC: 43405-005-08", "Active Ingredients": "Menthol 14.5% Methyl Salicylate 30%", "Inactive ingredients": "Chlorophyll, ethyl alcohol, mineral oil, rose oil", "When using this product": "■ avoid contact with eyes or mucous membranes ■ do not bandage tightly", "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 this drug 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: 2026-02-15T12:05:53.037477 · Updated: 2026-03-14T23:08:19.346855