Eagle Brand Medicated Oil

SPL v3

SPL

SPL Set ID d9a93daa-4e24-6690-e053-2a95a90a147c

Route

TOPICAL

Published

Effective Date 2022-03-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Menthol (14.5 g) Salicylic Acid (30 g)

Inactive Ingredients

D&c Yellow No. 11 Alcohol Mineral Oil Rose Oil D&c Green No. 6

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-03-04

Description

Menthol 14.5% Methyl Salicylate 30.0%

Purpose

Topical Analgesic Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 14.5% Methyl Salicylate 30.0%

Uses

temporarily relieves minor muscle and joint pain due to : ■simple backache ■ arthritis ■ strains ■ bruises

■ sprains

Warnings

For external use only

Directions

■ Adults and children 2 years and over: apply to affected area not more than 3 to 4 time daily.

■ Children under 2 years of age: ask a doctor

Package Label

Active Ingredient

Menthol 14.5%

Methyl Salicylate 30.0%

Inactive Ingredients

D&C Yellow No. 11, D&C Green No. 6, ethyl alcohol, mineral oil, rose oil

When Using This Product

■ use only as directed

■ do not get into eyes or mucous membranes

■ do not apply to wound or damaged skin.

■ do not bandage tightly

Stop Use and Ask A Doctor If

■ excessive skin irritation develops

■ pain worsens or does not improve within 7 days, or clears up and appears again in a few days

Keep This Drug Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

temporarily relieves minor muscle and joint pain due to : ■simple backache ■ arthritis ■ strains ■ bruises

■ sprains

Purpose

Topical Analgesic

Warnings

For external use only

Directions

■ Adults and children 2 years and over: apply to affected area not more than 3 to 4 time daily.

■ Children under 2 years of age: ask a doctor

Package Label

Active Ingredient

Menthol 14.5%

Methyl Salicylate 30.0%

Inactive Ingredients (Inactive ingredients)

D&C Yellow No. 11, D&C Green No. 6, ethyl alcohol, mineral oil, rose oil

When Using This Product (When using this product)

■ use only as directed

■ do not get into eyes or mucous membranes

■ 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)

■ excessive skin irritation develops

■ pain worsens or does not improve within 7 days, or clears up and appears again in a few days

Keep This Drug Out of Reach of Children (Keep this drug out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

[{"name": "D&C YELLOW NO. 11", "unii": "44F3HYL954", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "D&C GREEN NO. 6", "unii": "4QP5U84YF7", "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"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor muscle and joint pain due to : ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains", "Purpose": "Topical Analgesic Topical Analgesic", "Warnings": "For external use only", "Directions": "■ Adults and children 2 years and over: apply to affected area not more than 3 to 4 time daily. ■ Children under 2 years of age: ask a doctor", "Active Ingredient": "Menthol 14.5% Methyl Salicylate 30.0%", "Inactive ingredients": "D&C Yellow No. 11, D&C Green No. 6, ethyl alcohol, mineral oil, rose oil", "When using this product": "■ use only as directed ■ do not get into eyes or mucous membranes ■ do not apply to wound or damaged skin. ■ do not bandage tightly", "Stop use and ask a doctor if": "■ excessive skin irritation develops ■ pain worsens or does not improve within 7 days, or clears up and appears again in a few days", "Keep this drug out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:40.174028 · Updated: 2026-03-14T23:03:50.462651