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

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

ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]
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NDC 54273-009-01
Set ID 4d91baf3-9655-4786-93b8-aa0d93fe0bf9
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 16%

  • 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 this product
    • on open wounds, damaged or irritated skin
    • with a heating pad or TENS device
    • after expiration date

    When using this product

    • to avoid excess application, press applicator gently against skin
    • 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 not more than 4 times daily

    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, Propylene Glycol, SD Alcohol 40-B, Tea Tree Oil, Vanillyl Butyl Ether, Water.

    †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 - 89 mL Bottle Carton

    ZIM'S™
    MAX-
    FREEZE
    PRO FORMULA

    DEEP PENETRATING
    PAIN RELIEF

    - FAST ACTING
    - LONG LASTING
    - VANISHING SCENT

    Bottle Shaped for
    Easy Application

    COLD THERAPY
    COOLING LIQUID
    with 16% Menthol

    3 fl oz (89mL)

    PRINCIPAL DISPLAY PANEL - 89 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE   PRO FORMULA
    menthol, unspecified form liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54273-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM160 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54273-009-011 in 1 CARTON08/20/2018
    189 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34808/20/2018
    Labeler - KOBAYASHI Healthcare International, Inc. (156391729)
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