Label: ZIMS MAX FREEZE PRO FORMULA- menthol, unspecified form gel

  • NDC Code(s): 54273-006-01, 54273-006-02, 54273-006-03
  • Packager: KOBAYASHI Healthcare International, Inc.
  • 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 May 10, 2018

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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 WHOLE (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)
    Registrant - KOBAYASHI America Manufacturing, LLC (079852150)
    Establishment
    NameAddressID/FEIBusiness Operations
    KOBAYASHI America Manufacturing, LLC079852150PACK(54273-006) , LABEL(54273-006)
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