EAGLE BRAND MEDICATED OIL- menthol, methyl salicylate oil

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Menthol 14.5%

Methyl Salicylate 30.0%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor muscle and joint pain due to:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only

When using this product

• use only as directed.
• do not get into eyes or mucous membranes.
• do not apply to wounds or damaged skin.
• do not bandage tightly.

Stop use and ask 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.

Directions

• Adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily.
• Children under 2 years: ask a doctor.

Inactive Ingredients

Chlorophyll, ethyl alcohol, mineral oil, rose oil

Questions?

Refer questions or to report serious side effects to 1-800-777-6717 or 1-800-645-0769.

Package Label

24ml NDC: 60954-018-24

36ml NDC: 60954-018-36

INGREDIENTS AND APPEARANCE

EAGLE BRAND  MEDICATED OIL
menthol, methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60954-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
CHLOROPHYLL (UNII: 00WNZ48OR9)
ALCOHOL (UNII: 3K9958V90M)
ROSE OIL (UNII: WUB68Y35M7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60954-018-24	1 in 1 BOX	04/01/2026
1		24 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 60954-018-36	1 in 1 BOX	04/01/2026
2		36 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2026

Labeler - PT. EAGLE INDO PHARMA (728682519)

Establishment
Name	Address	ID/FEI	Business Operations
PT. EAGLE INDO PHARMA		728682519	manufacture(60954-018)