EAGLE MEDICATED- menthol methyl salicylate oil 
Borden Company (Private) Limited

----------

Eagle Brand Medicated Oil

Active Ingredient

Menthol 14.5%
Methyl Salicylate 30.0%

Purpose

Topical Analgesic

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 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.

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

Package Label

package label

EAGLE  MEDICATED
menthol methyl salicylate oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14.5 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
ALCOHOL (UNII: 3K9958V90M)  
MINERAL OIL (UNII: T5L8T28FGP)  
ROSE OIL (UNII: WUB68Y35M7)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43405-006-241 in 1 BOX03/04/2022
124 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:43405-006-361 in 1 BOX03/04/2022
236 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:43405-006-031 in 1 BOX03/04/2022
33 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/04/2022
Labeler - Borden Company (Private) Limited (595109711)
Establishment
NameAddressID/FEIBusiness Operations
Eagle Indo Pharma, PT728682519manufacture(43405-006)

Revised: 10/2024
Document Id: 238a76dd-0b55-474d-e063-6394a90a65a0
Set id: d9a93daa-4e24-6690-e053-2a95a90a147c
Version: 3
Effective Time: 20241002
 
Borden Company (Private) Limited