Label: ALCOCLEAN HAND SANITIZER- ethyl alcohol gel

  • NDC Code(s): 53113-095-08
  • Packager: GADAL Laboratories, Inc
  • 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 July 24, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available

  • Inactive Ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice, Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine.

  • Directions

    Put a thumbnail size amount in your palm and rub your hands together briskly until dry. Children under 6 years of age should be supervised when using.

  • Warning

    Flammable. Keep away from flames. Keep out of eyes. In case of eye contact immediately flush eyes with water then contact physician. If swallowed, contact physician. For external use only. Do not store above 110°F.

    Keep out of reach of children.

  • Other Information

    Store at room temperature.

  • SPL UNCLASSIFIED SECTION

    Made with 65% Alcohol

    Kills 99.9% of germs!

    Eliminates Harmful Bacteria
    Leaves Hands Feeling Refreshed

    GOOD MANUFACTURING PRACTICE

    GMP

    QUALITY PRODUCT

    MADE IN THE USA

    PCO FOODS

    Distributed by: PCO Foods 1110 Powers Place Alpharetta, GA, 30009 • pcofoods.com • sales@pcofoods.com

  • Packaging

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ALCOCLEAN HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-095-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/27/2020
    Labeler - GADAL Laboratories, Inc (841305639)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639manufacture(53113-095)