Label: ZIMS MAX FREEZE- lidocaine hydrochloride and menthol, patch

  • NDC Code(s): 54273-010-01
  • 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

    Active ingredientsPurpose
    Lidocaine HCl 4%Topical anesthetic
    Menthol 1%Topical analgesic
  • Uses

    For the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • more than 1 patch on your body at a time
    • if you are allergic to any ingredients in this product
    • on open wounds, damaged or irritated skin
    • with a heating pad or TENS device or other topical analgesics
    • 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
    • may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time
    • if severe burning sensation occurs, discontinue use immediately
    • may leave a blue stain on skin, which is safe and can be removed by washing with soap and water
    • avoid contact with silk
    • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the active ingredients that can produce serious adverse effects if a child or pet chews or ingests this patch

    Stop use and ask a doctor if

    • burning sensation is painful and persistent
    • condition worsens
    • rash, itching, redness, swelling, blistering 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 and pets. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and over:

    • clean and dry affected area
    • remove film from patch and apply to the skin (see illustration)
    • apply 1 patch at a time to affected area, not more than 3 to 4 times daily

    Children under 12 years of age:

    • consult a doctor
  • Other information

    • store in a cool place away from direct sunlight
  • Inactive ingredients

    FD&C Blue No. 1, Glycerin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Polyvinyl Alcohol, Povidone, Propylene Glycol, Propylparaben, Sodium Polyacrylate, Sodium Polyacrylate Starch, Sorbitan Oleate, Sorbitol, Tartaric Acid, Vanillyl Butyl Ether, Water

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box

    ZIM'S™
    MAX-
    FREEZE

    LIDOCAINE 4%
    & MENTHOL

    HYDRO COOLING
    PAIN RELIEF PATCH

    DEEP
    PENETRATING

    • LIDOCAINE
    • MENTHOL
    • EXTRA COOLING

    Fast Acting & Long Lasting
    Hydrated Gel Patch

    5 PATCHES

    3 15/16" X 5 1/2" (10 cm X 14 cm)
    Individually Packaged

    BACK, Hip, Neck, Shoulder, Knee

    PRINCIPAL DISPLAY PANEL - 5 Patch Pouch Box
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE 
    lidocaine hydrochloride and menthol, patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54273-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS760 mg
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM190 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYACRYLIC ACID (300000 MW) (UNII: A8371R0U5J)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SORBITOL (UNII: 506T60A25R)  
    TARTARIC ACID (UNII: W4888I119H)  
    VANILLYL BUTYL ETHER (UNII: S2ULN37C9R)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54273-010-015 in 1 BOX02/01/2022
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01702/01/2022
    Labeler - KOBAYASHI Healthcare International, Inc. (156391729)
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