Label: ZIMS ARNICA MAX- menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 14, 2014

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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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