Label: EAGLE MEDICATED- menthol methyl salicylate oil

  • NDC Code(s): 43405-005-08
  • Packager: Borden Company (Private) Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 14, 2022

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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 joint associated with : ■ simple backache ■ strains ■ bruises ■ sprains

  • Warning

    For external use only

  • Do not use

    ■ on woulds or damaged skin ■ with a heating pad

  • When using this product

    ■ avoid contact with eyes or mucous membranes

    ■ 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

    To avoid accidental poisoning, if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Use only as directed ■ adults and children 2 years and older: 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 Green No. 6, D&C Yellow No. 11, ethyl alcohol, mineral oil, rose oil

  • Question?

    1-800-777-6717 or 1-800-645-0789

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    EAGLE  MEDICATED
    menthol methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-005
    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:43405-005-081 in 1 BOX03/04/2022
    18 mL in 1 BOTTLE, WITH APPLICATOR; 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
    Borden Company (Private) Limited595109711manufacture(43405-005)
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