Label: ZIMS MAX FREEZE- menthol, lidocaine and menthyl salicylate patch

  • 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 February 10, 2016

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  • ACTIVE INGREDIENTS:

    NATURAL Menthol USP 5%

    Lidocaine 4%

    Methyl Salicylate 0.04%

  • PURPOSE:

    Topical Analgesic

    Topical Analgesic

    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:

    Use only as directed.

    • For external use only

    • Do Not use if you are allergic to any ingredient in Zim's Max-Freeze Patch
    • Do Not use if you have had allergic reaction to aspirin or other salicylate products
    • Use caution with blood thinning medications, NSAIDS, steroids or nonsteroidal anti-inflammatory drugs
    • If conditions worsens or symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician
    • Avoid contact with eyes or mucous membranes

    • PREGNANCY - Breast Feeding Warning: If pregnant or breastfeeding, ask a physician before use.
    • Do not use with other topical products.
    • Do not use with heating devices.
    • Do not use on open wounds, damaged or irritated skin
    • Keep away from excessive heat.

    • Keep this and all medicine out of reach of children.
    • Accidental ingestion: Seek professional help and contact Poison Control immediately
    • Under age 12 Consult a physician before use.
  • DIRECTIONS:

    Adults/children 12 years and older

    • Strip off the polyethylene film and place adhesive pad over affected area.
    • Change pad 1 or 2 times a day.
    • Wash Hands after applying patch.
  • OTHER:

    Store at room temperature - do not exceed 86° Fahrenheit

  • INACTIVE INGREDIENTS:

    †Aloe Barbadensis Leaf Extract, Aluminum Hydroxide, Alcohol, Arnica Extract, Borneol, Camphor, EDTA-2Na, Glycerin, NP-700, PVPP, Tartaric Acid, Titanium Dioxide, Water.

    Distributed by: Perfecta Products, Inc., North Lima, OH 44452

    (800) 319-2225-www.ZimsUSA.com

    ©2015 Perfecta Products, Inc.®

  • Principal Display Panel - Medium Pouch Label

    ZIM's

    MAX

    FREEZE

    PATCHES

    MUSCLE & JOINT*

    Description: Zim's Max-Freeze Patch

    Size: Medium

    Lot#: 123456

    Expiration Date - 1/1/19

    Principal Display Panel - Medium Pouch Label
  • Principal Display Panel - Large Pouch Label

    ZIM's

    MAX

    FREEZE

    PATCHES

    MUSCLE & JOINT*

    Description: Zim's Max-Freeze Patch

    Size: Large

    Lot#: 123456

    Expiration Date - 12/25/18

    Principal Display Panel - Large Pouch Label
  • Principal Display Panel - Extra Large Pouch Label

    ZIM's

    MAX

    FREEZE

    PATCHES

    MUSCLE & JOINT*

    Description: Zim's Max-Freeze Patch

    Size: Extra Large

    Lot#: 123456

    Expiration Date - 1/5/19

    Principal Display Panel - Extra Large Pouch Label
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE 
    menthol, lidocaine and menthyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-113
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-0.4 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALCOHOL (UNII: 3K9958V90M)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    BORNEOL (UNII: M89NIB437X)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    TARTARIC ACID (UNII: W4888I119H)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-113-066 in 1 CANISTER
    11 in 1 POUCH
    11 in 1 PATCH; Type 0: Not a Combination Product
    2NDC:66902-113-044 in 1 CANISTER
    21 in 1 POUCH
    21 in 1 PATCH; Type 0: Not a Combination Product
    3NDC:66902-113-033 in 1 CANISTER
    31 in 1 POUCH
    31 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2016
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-113)
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