ZIMS MAX FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS, INC.]

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ZIMS MAX FREEZE (MENTHOL) GEL [NATURAL ESSENTIALS, INC.]
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NDC 66902-014-03, 66902-014-04, 66902-400-05
Set ID c85b499a-bb7a-4fc1-9401-4966d7e2a07e
Category HUMAN OTC DRUG LABEL
Packager NATURAL ESSENTIALS, INC.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Natural Menthol USP 3.7%

  • Purpose

    Topical Analgesic

  • Use

    • For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.
  • Warnings

    For external use only

    Do not use

    • if you are allergic to any ingredient in Zim's Max-Freeze
    • 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

    • 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 heal

    Stop use and ask a doctor if

    • condition worsens or
    • symptoms persist for more than 7 days or dear 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, got medical help or contact a poison control center right away.

  • Directions

    Adults and children 12 years and older

    • Apply and gently massage painful joint and/or muscles.
    • Repeat as needed no more than 4 times a day.
    • Wash hands after each use with cold water.
  • Other information

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

  • Inactive ingredients

    †Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, Carbomer, Ethylhexylglycerin, †Ilex Paraguarionsis Leaf Extract, Isopropyl Alcohol, Phenoxyethanol, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.

    †Symbol before the ingredient indicates certified organic.

  • Principal Display Panel - 4 oz Tube Label

    ZIMS®

    MAX FREEZE

    MUSCLE & JOINT*

    Greaseless, vanishing scent formula.
    Organic ilex & aloe, arnica,
    vitamin e and tea tree oil.
    Paraben & sulfate free.

    Nature Science

    Net Wt 4 oz. (113.4g)

    Principal Display Panel - 4 oz Tube Label
  • Principal Display Panel - 3 oz Bottle Label

    ZIMS®

    MAX FREEZE

    MUSCLE & JOINT*

    Greaseless, vanishing scent
    formula. Organic ilex & aloe,
    arnica, vitamin e and tea tree oil.

    Nature Science

    89 mL (3 fl oz)

    Principal Display Panel - 3 oz Bottle Label
  • PRINCIPAL DISPLAY PANEL - 5 g SAMPLE Pouch Label

    ZIM'S®
    MAX-
    FREEZE

    PAIN RELIEF

    Greaseless, vanishing scent formula.
    Organic ilex & aloe, arnica,
    vitamin e and tea tree oil.
    Paraben & sulfate free.

    Nature Science

    ZimsUSA.com
    5g SAMPLE

    PRINCIPAL DISPLAY PANEL - 5 g SAMPLE Pouch Label
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM37 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-014-04113.4 mL in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    2NDC:66902-014-0389 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/01/2014
    ZIMS MAX FREEZE 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM37 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-400-051 in 1 BOTTLE, WITH APPLICATOR03/29/2018
    15 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/01/2014
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-014, 66902-400)
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