ZIMS MAX FREEZE (MENTHOL, LIDOCAINE AND MENTHYL SALICYLATE) PATCH [NATURAL ESSENTIALS, INC.]

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ZIMS MAX FREEZE (MENTHOL, LIDOCAINE AND MENTHYL SALICYLATE) PATCH [NATURAL ESSENTIALS, INC.]
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NDC 66902-113-03, 66902-113-04, 66902-113-06
Set ID ce4a477a-f947-422e-85ac-72b16f7b92f2
Category HUMAN OTC DRUG LABEL
Packager NATURAL ESSENTIALS, INC.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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