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

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ZIMS ARNICA MAX (MENTHOL) GEL [NATURAL ESSENTIALS, INC.]
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NDC 66902-700-03, 66902-700-04
Set ID dfc88cae-cf19-4a9e-a707-160938979b3c
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 2%

  • PURPOSE:

    TOPICAL ANALGESIC

  • USE:

    For the temporary relief of minor aches and pains of muscle 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 clears 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 on open wounds
    -
    Keep away from excessive heat or open flame

    -
    KEEP AWAY FROM CHILDREN
    -
    If swallowed, seek professional help and contact Poison Control immediately.
  • DIRECTIONS:

    Adults/children 12 years and older

    -
    Apply-gently massage painful joints/muscles.
    -
    Repeat as needed no more than 4 times a day.
    -
    Wash hands after each use with cold water
  • OTHER:

    Store in a cool, dry areas - close cap tight. Do not use if seal is broken.

  • INACTIVE INGREDIENTS:

    Alcohol Denatured, Aloe Vera, Arnica, Carbomer, Glycerine, Methylparaben, Propylene Glycol, Triethanolamine, Water

  • Principal Display Panel - Tube Label

    SPECIAL FORMULATED WITH ARNICA
    ARNICA
    ZIM'S    ®
    MAX

    MAY HELP BRUISING & SWELLING FROM
    INJURIES, PAIN AND STIFFNESS

    Net Wt 4 oz. (113.4g)

    Principal Display Panel - Tube Label
  • Principal Display Panel - Bottle Label

    SPECIAL FORMULATED WITH ARNICA
    ARNICA
    ZIM'S    ®
    MAX

    MAY HELP BRUISING & SWELLING FROM
    INJURIES, PAIN AND STIFFNESS

    Net Wt 3 fl oz (89 mL)

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    ZIMS ARNICA MAX 
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-700
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-700-040.002268 L in 1 TUBE
    2NDC:66902-700-030.00178 L in 1 BOTTLE, WITH APPLICATOR
    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(66902-700)
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