EAGLE BRAND MEDICATED ROLL ON- menthol, methyl salicylate oil

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

• Menthol 14.5%
• Methyl Salicylate 30%

Purpose

Topical analgesic

Uses

Temporarily relieves the minor aches and pains of muscles and joints associated with:

• simple backache
• strains
• bruises
• sprains

Warnings

For external use only

Do not use

• on wounds or damage skin
• with a heating pad

Ask a doctor before use if

you have redness over affected area

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 out of reach of children

Avoid accidental poisoning.

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

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

Inactive ingredients

Chlorophyll, ethyl alcohol, mineral oil, rose oil

Questions?

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

Package Label

8ml NDC: 60954-020-08

INGREDIENTS AND APPEARANCE

EAGLE BRAND  MEDICATED ROLL ON
menthol, methyl salicylate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60954-020
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
CHLOROPHYLL (UNII: 00WNZ48OR9)
ROSE OIL (UNII: WUB68Y35M7)
ALCOHOL (UNII: 3K9958V90M)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60954-020-08	1 in 1 BOX	04/01/2026
1		8 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(60954-020)