eagle brand medicated oil

eagle brand medicated oil
SPL v3
SPL
SPL Set ID da338796-de9c-be51-e053-2a95a90a2509
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

Purpose

Topical Analgesic Topical Analgesic

Description

Menthol 14.5% Methyl Salicylate 30.0%


Medication Information

Warnings

For external use only

Uses

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

■ sprains

Purpose

Topical Analgesic

Topical Analgesic

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

Inactive Ingredients

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

Description

Menthol 14.5% Methyl Salicylate 30.0%

Package Label

Active Ingredient

Menthol 14.5%

Methyl Salicylate 30.0%

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

Warnings

For external use only

Uses

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

■ sprains

Purpose

Topical Analgesic

Topical Analgesic

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

Inactive Ingredients (Inactive ingredients)

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

Package Label

Active Ingredient

Menthol 14.5%

Methyl Salicylate 30.0%

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


Raw Label Data

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