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 August 23, 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 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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