Label: ANGEL FALLS HAND SANITIZER- ethyl alcohol 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 August 18, 2012

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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
    ANGEL FALLS HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52979-8001
    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:52979-8001-129 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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