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

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ZIMS MAX FREEZE (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]
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NDC 54273-003-01, 54273-003-02
Set ID 208d7902-6a97-4534-947b-45cbc8f9051c
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

    SHAKE WELL

  • Active ingredient

    Natural Menthol USP 3.7%

  • 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

    Flammable

    Keep away from fire or flame and heated surfaces

    Do not use

    • if you are allergic to any ingredient in Zim's Max-Freeze
    • on open wounds, damaged or irritated skin
    • with a heating pad or TENS device
    • after expiration date

    When using this product

    • 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

    • 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 using roller ball 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

    †Aloe Barbadensis Leaf Extract, †Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, †Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

    †Symbol before the ingredient indicates certified organic.

  • QUESTIONS

    Consumer Comments Call: 800-319-2225

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

    ZIM'S™
    MAX
    FREEZE

    ADVANCED FORMULA
    - Muscle & Joint -
    PAIN RELIEF

    Greaseless,
    vanishing scent
    with organic ilex,
    aloe & arnica plus
    vitamin e and
    tea tree oil.

    Paraben & sulfate free.

    COOLING ROLL-ON
    with Menthol

    Net Wt 3oz. (85g)

    PRINCIPAL DISPLAY PANEL - 85 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54273-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM37 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54273-003-0185 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/01/2017
    2NDC:54273-003-02102 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34809/01/2017
    Labeler - KOBAYASHI Healthcare International, Inc. (156391729)
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