EZ MASSAGER 4 EXTRA STRENGTH (MENTHOL) GEL [CUNNINGPAC]

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EZ MASSAGER 4 EXTRA STRENGTH (MENTHOL) GEL [CUNNINGPAC]
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NDC 71633-004-01
Set ID 54d06c10-d139-1399-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager CunningPac
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 symptoms persisist for more than 7 days

    * Symptoms clear up and occur again within a few days

    * Excessive skin irratation occurs

    * You are pregnant or breast feeding

  • INACTIVE INGREDIENT

    GINKGO BILOBA LEAF OIL

    PANAX GINSENG ROOT OIL

    ARNICA MONTANA

    THYMUS VULGARIS LEAF

    WATER

    ALCOHOL

    SODIUM POLYACRYLATE (8000 MW)

    DIMETHICONE 200

    ETHYLHEXYLGLYCERIN

  • INDICATIONS & USAGE

    Instant relief for:

    Arthritis

    Backache

    Bruises

    Cramps

    Sprains

    Strains

    WHEN USING THIS PRODUCT:

    * Avoid contact with eyes or micous 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 Poisen Control Center right away.

  • ACTIVE INGREDIENT

    Menthol 2 %

  • PRINCIPAL DISPLAY PANEL

    ezmassager04

  • INGREDIENTS AND APPEARANCE
    EZ MASSAGER 4  EXTRA STRENGTH
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71633-004
    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
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE 200 (UNII: RGS4T2AS00)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71633-004-0112 in 1 CARTON08/01/2017
    112 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2017
    Labeler - CunningPac (539075187)
    Registrant - EZM Distributions,LLC (080627876)
    Establishment
    NameAddressID/FEIBusiness Operations
    CunningPac539075187manufacture(71633-004)
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