Label: EZ MASSAGER 4 EXTRA STRENGTH- menthol gel

  • 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 November 30, 2017

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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

    Ginkgo biloba leaf oil

    Panax ginseng root oil

    Arnica Montana

    Ethylhexylglycerin

    Thymus vulgaris leaf

    Water

    Alcohol

    Dimethicone 200

    Sodium polyacrylate (8000 mw)

  • 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 4 Ez Massager 4

  • INGREDIENTS AND APPEARANCE
    EZ MASSAGER 4  EXTRA STRENGTH
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71555-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORM (Gel) Size
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71555-004-02100 mL in 1 CANISTER; Type 0: Not a Combination Product08/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2017
    Labeler - BlackPort Distribution (539179900)
    Registrant - EZM Distributions, LLC (080627876)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cunningpac CC539075187manufacture(71555-004)
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