WATER MOUNTAIN HAND SANITIZER (ETHYL ALCOHOL) GEL [CUARTA DIMENSION USA, INC.]

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WATER MOUNTAIN HAND SANITIZER (ETHYL ALCOHOL) GEL [CUARTA DIMENSION USA, INC.]
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NDC 52979-8006-1
Set ID e7820d0b-5f03-4e48-9cae-f3f007719b66
Category HUMAN OTC DRUG LABEL
Packager CUARTA DIMENSION USA, INC.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active ingredient
    Ethyl Alcohol 62%
  • PURPOSE

    Purpose
    Antiseptic
  • INDICATIONS & USAGE

    Uses
    For hand washing to decrease bacteria on the skin
    Recommended for repeated use
  • WARNINGS

    Warnings
    For external use only.
    Avoid contact with broken skin.
    Flammable. Keep away from heat and flame.
    Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    Children under 6 of age should be supervised when using this product.
  • DOSAGE & ADMINISTRATION

    Directions
    Not recommanded for infants
    Wet hands thoroughly with product and allow to dry without wiping
    Children under 6 of age should be supervised when using this product.
    Other Information
    Do not store above 105 degrees F.
    May discolor some fabrics.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine, Aloe Barbadensis Leaf Juice, Fragrance
  • PRINCIPAL DISPLAY PANEL

    image of bottle label
  • INGREDIENTS AND APPEARANCE
    WATER MOUNTAIN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52979-8006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52979-8006-129 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/18/2012
    Labeler - CUARTA DIMENSION USA, INC. (956733336)
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