EZ MASSAGER 2 ORIGINAL (MENTHOL) GEL [BLACKPORT DISTRIBUTION]

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EZ MASSAGER 2 ORIGINAL (MENTHOL) GEL [BLACKPORT DISTRIBUTION]
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NDC 71555-002-01
Set ID 5a92a956-c001-3d14-e053-2a91aa0af839
Category HUMAN OTC DRUG LABEL
Packager BlackPort Distribution
Generic Name
Product Class
Product Number
Application Number PART348
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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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