Label: EAGLE MEDICATED- menthol methyl salicylate oil

  • NDC Code(s): 43405-008-01, 43405-008-02, 43405-008-03, 43405-008-08, view more
    43405-008-13, 43405-008-24, 43405-008-36
  • Packager: Borden Company (Private) Limited
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 2, 2024

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  • 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

  • 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
    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 DrugM01705/14/2012
    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)
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