Label: ZIMS MAX FREEZE PRO FORMULA- menthol spray

  • NDC Code(s): 54273-008-01, 54273-008-02
  • Packager: KOBAYASHI Healthcare International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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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

    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 near sparks or while smoking
    • do not use in a small or confined space
    • avoid long term storage above 104° F (40° C)
    • do not puncture or incinerate. Contents under pressure.
    • do not expose to temperature exceeding 119° F (48° C)

    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
    • near face
    • 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
    • avoid inhalation

    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

    • spray affected area not more than 4 times daily
    • no need to rub
    • 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 locked tightly
  • Inactive ingredients

    1Aloe Barbadensis Leaf Extract, Arnica Extract, Glycerin, SD Alcohol 40-B, 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 - 96 g Can Label

    EXTRA STRENGTH

    ZIM'S™
    MAX-
    FREEZE

    PRO FORMULA

    - LONGER LASTING* -
    PAIN RELIEF

    -
    FAST ACTING
    -
    LONG LASTING
    -
    VANISHING SCENT

    CONTINUOUS
    COOLING SPRAY
    with 16% Menthol

    Net Wt 3.4oz (96g)
    *compared to original

    Continuous
    Multi-Way Spray

    Principal Display Panel - 96 g Can Label
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE   PRO FORMULA
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54273-008
    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 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54273-008-0196 g in 1 CAN; Type 0: Not a Combination Product09/24/2018
    2NDC:54273-008-02116 g in 1 CAN; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01709/24/2018
    Labeler - KOBAYASHI Healthcare International, Inc. (156391729)
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