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 Menthol Mthylslcylte Oil

Active Ingredients

Menthol 14.5%
Methyl Salicylate 30%


Purpose

Topical Analgesic

Topical Analgesic

Uses

temporarily relieves the minor aches and pains of muscle and joints associated with :

■simple backache ■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 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 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:43405-008
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)  
D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
ALCOHOL (UNII: 3K9958V90M)  
MINERAL OIL (UNII: T5L8T28FGP)  
ROSE OIL (UNII: WUB68Y35M7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43405-008-011 in 1 BOX05/14/2012
1NDC:43405-008-2424 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2NDC:43405-008-021 in 1 BOX05/14/2012
2NDC:43405-008-3636 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
3NDC:43405-008-131 in 1 BOX05/14/2012
3NDC:43405-008-033 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
4NDC:43405-008-081 in 1 BOX06/27/2022
48 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 finalpart34805/14/2012
Labeler - Borden Company (Private) Limited (595109711)
Establishment
NameAddressID/FEIBusiness Operations
Borden Company (Private) Limited595109711manufacture(43405-008)
Establishment
NameAddressID/FEIBusiness Operations
Eagle Indo Pharma728682519manufacture(43405-008)

Revised: 7/2022
Document Id: e2c5fde2-6887-6cb6-e053-2995a90a6714
Set id: 1ee49cad-84d4-42cf-aa83-c0da6f1b1b84
Version: 6
Effective Time: 20220701
 
Borden Company (Private) Limited