ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]

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  • ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]

ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]
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NDC 54273-006-01, 54273-006-02, 54273-006-03
Set ID b44beac3-1d20-434f-9a79-4fab1ac68791
Category HUMAN OTC DRUG LABEL
Packager KOBAYASHI Healthcare International, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Menthol 7%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • Simple backache
    • Arthritis
    • Strains
    • Bruises
    • Sprains
  • Warnings

    For external use only

    Rare cases of burns have been reported with products of this type

    Flammable: Keep away from fire or flame and heated surfaces

    Do not use

    • if you are allergic to any ingredient in this product
    • on open wounds, damaged or irritated skin
    • with a heating pad or TENS device
    • after expiration date

    When using this product

    • may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
    • do not bandage tightly
    • do not use otherwise than as directed
    • avoid contact with eyes or mucous membranes

    Stop use and ask a doctor if

    • burning sensation is painful and persistent
    • condition worsens
    • rash, itching, redness or excessive irritation of the skin develops
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children 12 years of age and over:
      • apply to affected area not more than 4 times daily
      • massage painful area until absorbed into skin
      • wash hands after each use with cold water

    Children under 12 years of age:

    • consult a doctor
  • Other information

    • store in a cool place away from direct sunlight
    • store with cap closed tightly
  • Inactive ingredients

    1Aloe Barbadensis Leaf Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Arnica Extract, Hydroxypropylcellulose, Isopropyl Alcohol, Propylene Glycol, Tea Tree Oil, Vanillyl Butyl Ether, Water.

    1
    Symbol before the ingredient indicates certified organic.
  • QUESTIONS

    Consumer Comments Call: 1-800-432-8629

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    KOBAYASHI Consumer Products, LLC
    P.O. Box 1191, Dalton, GA 30722

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Label

    EXTRA STRENGTH

    ZIM'S™
    MAX-
    FREEZE

    PRO FORMULA

    - LONGER LASTING* -
    PAIN RELIEF

    - FAST ACTING
    - LONG LASTING
    - VANISHING SCENT

    COLD THERAPY
    COOLING GEL
    with 7% Menthol

    Net Wt 4oz (113g)

    *compared to original

    PRINCIPAL DISPLAY PANEL - 113 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE   PRO FORMULA
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54273-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54273-006-01113 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    2NDC:54273-006-02136 g in 1 TUBE; Type 0: Not a Combination Product02/01/2019
    3NDC:54273-006-035 g in 1 PACKET; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34807/01/2018
    Labeler - KOBAYASHI Healthcare International, Inc. (156391729)
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