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

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ZIMS MAX FREEZE (MENTHOL AND LIDOCAINE) PATCH [NATURAL ESSENTIALS, INC.]
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NDC 66902-213-03, 66902-213-04, 66902-213-06
Set ID 58331771-ceea-4368-a82b-33807451857b
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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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine 4%

    Menthol USP 1%

  • Purpose

    Topical Analgesic

    Topical Analgesic

  • Use

    • For the temporary relief of pain.
  • Warnings

    For external use only

    Do not use

    • if you are allergic to any ingredient in Zim's Max-Freeze Patches
    • if you have had an allergic reaction to aspirin or other salicylate products
    • on open wounds, damaged or irritated skin
    • in large quantities, particularly on raw surfaces or blistered areas.

    Ask a doctor or pharmacist before use if you are

    • using blood thinning medications, steroids or non-steroidal anti-inflammatory drugs (NSAIDS)

    When using this product

    • a do not use other topical products
    • do not use with heating devices
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly
    • keep away from excessive heat

    Stop use and ask a doctor if

    • a condition worsens or
    • symptoms persist for more than 7 days or
    • clear up and occur again within a few days.

    If pregnant or breast feeding ask a physician before use.

    Keep out of reach of children. If put in the mouth get medical help or contact a poison control center right away.

  • Directions

    Adults/children 12 years and older

    • Strip off the polyethylene film and place adhesive patch over affected area
    • Change patch 1 or 2 rimes per day
    • Wash hands after applying patch
    • Under age 12, consult a physician before use
  • Other information

    Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.

  • Inactive ingredients

    Alcohol, Aloe Barbadensis Leaf Extract, Aluminum Hydroxide, Amica Extract, Bomeol, Camphor, EDTA-2Na, Glycerin, Methyl Salicylate, NP-700, PVPP, Tartaric Acid, Titanium Dioxide, Water.

    Distributed by Perfects Products. Inc., North Lima. Ohio 44452

    (800) 319-2225 • www.ZimsUSA.com

    ©2016 Perfects Products, Inc.® Made in China

  • Principal Display Panel - Canister Label

    ZIM'S®
    MAX-
    FREEZE
    PATCHES

    PAIN RELIEF

    LIDOCAINE & MENTHOL

    Targeted pain relief
    in an individually wrapped,
    easy to apply patch.

    M

    6 PATCHES

    3" X 5" (7.6 x 12.7 cm)

    Nature Science

    Principal Display Panel - Canister Label
  • Principal Display Panel - Patch Label

    ZIM'S®
    MAX
    FREEZE
    PATCHES

    MUSCLE & JOINT®

    Description: Zim's Max-Freeze Patch

    Size: Medium

    Lot#: 160301

    Expiration Date: 3/5/19

    Principal Display Panel - Patch Label
  • Principal Display Panel - Canister Label

    ZIM'S®
    MAX-
    FREEZE
    PATCHES

    PAIN RELIEF

    LIDOCAINE & MENTHOL

    Targeted pain relief
    in an individually wrapped,
    easy to apply patch.

    L

    4 PATCHES

    4" X 5.5" (10.2 x 14 cm)

    Nature Science

    Principal Display Panel - Canister Label
  • Principal Display Panel - Patch Label

    ZIM'S®
    MAX
    FREEZE
    PATCHES

    MUSCLE & JOINT®

    Description: Zim's Max-Freeze Patch

    Size: Large

    Lot#: 160305

    Expiration Date: 3/15/19

    Principal Display Panel - Patch Label
  • Principal Display Panel - Canister Label

    ZIM'S®
    MAX-
    FREEZE
    PATCHES

    PAIN RELIEF

    LIDOCAINE & MENTHOL

    Targeted pain relief
    in an individually wrapped,
    easy to apply patch.

    XL

    3 PATCHES

    4" X 8" (10.2 x 20.3 cm)

    Nature Science

    Principal Display Panel - Canister Label
  • Principal Display Panel - Patch Label

    ZIM'S®
    MAX
    FREEZE
    PATCHES

    MUSCLE & JOINT®

    Description: Zim's Max-Freeze Patch

    Size: Extra Large

    Lot#: 160310

    Expiration Date: 3/25/19

    Principal Display Panel - Patch Label
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE 
    menthol and lidocaine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-213
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 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)  
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-213-066 in 1 CANISTER
    11 in 1 PATCH; Type 0: Not a Combination Product
    2NDC:66902-213-044 in 1 CANISTER
    21 in 1 PATCH; Type 0: Not a Combination Product
    3NDC:66902-213-033 in 1 CANISTER
    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(66902-213) , REPACK(66902-213)
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