Label: EAGLE MEDICATED- menthol methyl salicylate oil

  • NDC Code(s): 60954-008-03, 60954-008-08, 60954-008-24, 60954-008-36
  • Packager: Eagle Indo Pharma
  • 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 July 1, 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 joints associated with :

    ■simple backache ■strains ■bruises ■sprains

  • Warning

    For external use only

  • Do not use

    ■ on wounds or damaged skin ■ with a heating pad

  • Ask a doctor before use if

    you have redness over affected area

  • 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 out of reach of children

    Keep 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 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 Green No. 6, D&C Yellow No. 11, ethyl alcohol, mineral oil, rose oil

  • Question?

    1-800-777-6717 or 1-800-645-0769

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    EAGLE  MEDICATED
    menthol methyl salicylate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60954-008
    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:60954-008-241 in 1 BOX06/27/2022
    124 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    2NDC:60954-008-361 in 1 BOX06/27/2022
    236 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    3NDC:60954-008-031 in 1 BOX06/27/2022
    33 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
    4NDC:60954-008-081 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 not finalpart34806/20/2012
    Labeler - Eagle Indo Pharma (728682519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eagle Indo Pharma728682519manufacture(60954-008)
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