Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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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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Drug Facts

Active Ingredients

Menthol 14.5%
Methyl Salicylate 30%


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 wound or damaged skin.
  • do not bandage tightly

Stop use and ask a doctor if

  • pain persists for more than 10 days
  • redness is present
  • conditions affect children under 12 years of age
  • discontinue use if excessive irritation of the skin develops

Keep this drug out of reach of children

Do not use otherwise than as directed keep out of the reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a poison control center right away.

Directions

  • Apply to affected area not more than 3 to 4 time daily.
  • This product should not be directed for use by children under 12 years of age.

Inactive ingredients

Chlorophyll, ethyl alcohol, mineral oil, rose oil

Package Label

image description

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
CHLOROPHYLL (UNII: 00WNZ48OR9)  
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 BOX
1NDC: 43405-008-2424 mL in 1 BOTTLE, GLASS
2NDC: 43405-008-021 in 1 BOX
2NDC: 43405-008-3636 mL in 1 BOTTLE, GLASS
3NDC: 43405-008-131 in 1 BOX
3NDC: 43405-008-033 mL in 1 BOTTLE, GLASS
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) Limited 595109711manufacture(43405-008)

Revised: 1/2015
 
Borden Company (Private) Limited


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