ZIMS MAX FREEZE CONTINUOUS (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]

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ZIMS MAX FREEZE CONTINUOUS (MENTHOL) SPRAY [NATURAL ESSENTIALS INC.]
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NDC 66902-416-04
Set ID eb55ad62-ccfc-4072-8ab0-6cc729f0656c
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 INGREDIENT:

    NATURAL Menthol USP 3.7%

  • PURPOSE:

    Topical Analgesic

  • *USES:

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

  • WARNINGS:

    Use only as directed.

    • For external use only
    • If condition worsens or if 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 breast feeding, 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 or open flame.

    • Keep this and all medicine out of reach of children.
    • Accidental ingestion: Seek professional help and contact Poison Control immediately.
    • CONTENTS UNDER PREASSURE, DO NOT PUNCTURE OR INCINERATE.
    • DO NOT STORE ABOVE 120°F (48°C)
  • DIRECTIONS:

    Adults and children 12 years and older

    • Spray evenly over painful joints and/or muscles.
    • No need to rub. Leave sprayed area to dry.
    • Repeat as necessary, no more than 4 times a day.
    • Do not spray near face. Spray in hands to apply near face.
    • If using hands to apply, wash with cold water when finished.
  • OTHER:

    Store in cool, dry area - close cap tight

  • INACTIVE INGREDIENTS:

    †Aloe Barbadensis Leaf Extract, Arnica Extract, Camphor, †llex Paraguariensis Leaf Extract, SDA-39C, Tea Tree Oil, Tocopheryl Acetate (Vitamin E Acetate), Water.

  • Principal Display Panel - Zim's Max Freeze Continuous Spray Label

    ZIM'S®

    MAX

    FREEZE

    COUNTINUOS SPRAY

    MUSCLE & JOINT*

    Greaseless, vanishing scent formula.

    Organic ilex & aloe, arnica, vitamin e
    and tea tree oil.

    Nature Science

    118.29 mL (4 fl oz)

    Principal Display Panel - Zim's Max Freeze Continuous Spray Label
  • INGREDIENTS AND APPEARANCE
    ZIMS MAX FREEZE   CONTINUOUS
    menthol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL37 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-416-041 g in 1 CAN; Type 0: Not a Combination Product01/01/2016
    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(66902-416)
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