Label: EZ MASSAGER 2 ORIGINAL- menthol gel

  • Category: HUMAN OTC DRUG LABEL

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 October 9, 2018

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  • DOSAGE & ADMINISTRATION

    • Massage into painful area until thoroughly absorbed into skin
    • Repeat as necessary but not more than 3 to 4 times per day
  • WARNINGS

    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 the affected area
    • Conditions worsen or sypmtoms persist for more than 7 days
    • Symptons clear up and occur again within a few days
    • Excessive skin irritation occurs
    • You are pregnant or breast feeding
  • INACTIVE INGREDIENT

    Aqua/distilled/deionized

    Rectified Alcohol

    Arnica water-soluble

    Beneficial Herbal Extract

    Perservative 9010

  • INDICATIONS & USAGE

    Instant relief for:

    Arthritis

    Backache

    Bruises

    Cramps

    Sprains

    Strains

    WHEN USING THIS PRODUCT:

    • Avoid contact with eyes or mucous membranes
    • Do not bandage tightly
  • PURPOSE

    Topical Analgesic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN: If swallowed, get medical help or contact a Poison Control Center right away.

  • ACTIVE INGREDIENT

    Menthol, 2%

  • PRINCIPAL DISPLAY PANEL

    Ez Massager 2 Ez Massager 2

  • INGREDIENTS AND APPEARANCE
    EZ MASSAGER 2  ORIGINAL
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71555-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA (UNII: O80TY208ZW)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    Product Characteristics
    Colorwhite (Topical Gel) Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71555-002-01100 mL in 1 CANISTER; Type 0: Not a Combination Product08/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/31/2017
    Labeler - BlackPort Distribution (539179900)
    Registrant - EZM Distributions, LLC (080627876)
    Establishment
    NameAddressID/FEIBusiness Operations
    CUNNINGPAC CC539075187manufacture(71555-002)
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