Label: EAGLE MEDICATED- menthol methyl salicylate oil

  • NDC Code(s): 43405-006-03, 43405-006-24, 43405-006-36
  • 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 Ingredient

    Menthol 14.5%
    Methyl Salicylate 30.0%

  • Purpose

    Topical Analgesic

    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

    ■ excessive skin irritation develops

    ■ pain worsens or does not improve within 7 days, or clears up and appears again in a few days

  • 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:43405-006
    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:43405-006-241 in 1 BOX03/04/2022
    124 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:43405-006-361 in 1 BOX03/04/2022
    236 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    3NDC:43405-006-031 in 1 BOX03/04/2022
    33 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 finalpart34803/04/2022
    Labeler - Borden Company (Private) Limited (595109711)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Indo Pharma, PT728682519manufacture(43405-006)
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