EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]

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EAGLE MEDICATED (MENTHOL METHYL SALICYLATE) OIL [BORDEN COMPANY (PRIVATE) LIMITED ]
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NDC 43405-008-01, 43405-008-02, 43405-008-03, 43405-008-13, 43405-008-24, 43405-008-36
Set ID 1ee49cad-84d4-42cf-aa83-c0da6f1b1b84
Category HUMAN OTC DRUG LABEL
Packager Borden Company (Private) Limited
Generic Name
Product Class
Product Number
Application Number PART348
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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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