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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 not finalpart34803/04/2022
Labeler - Borden Company (Private) Limited (595109711)
Establishment
NameAddressID/FEIBusiness Operations
Eagle Indo Pharma, PT728682519manufacture(43405-006)

Revised: 3/2022
Document Id: da340970-8286-8065-e053-2a95a90a57b3
Set id: d9a93daa-4e24-6690-e053-2a95a90a147c
Version: 2
Effective Time: 20220314
 
Borden Company (Private) Limited