Label: GFS BIOPROTECT HAND SANITIZER ALOE VERA- benzalkonium chloride aerosol, foam

  • 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 3, 2013

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  • DESCRIPTION

    BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with  Water,1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, C12-C15 Pareth-3, Polyaminopropyl biguanide, Caprylyl glucoside, Citronellol, Sorbic Acid, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and  D and C Green No.5. It is alcohol-free, non-toxic and kills 99.99% of germs.

  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%.............................................Antiseptic

  • PURPOSE

    • Antispetic
  • INDICATIONS & USAGE

    • Hand sanitizer to help decrease bacteria on skin
    • Recommended for repeated use
  • WARNINGS

    • For external use only
    • Do not use in ears or mouth
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach on children
    • Children must be supervised in use of this product
  • DOSAGE & ADMINISTRATION

    • Apply a small amount into your palm and throughly spread on both hands
    • Rub into skin until dry
  • GENERAL PRECAUTIONS

    • Review MSDS before handling the product
  • WHEN USING

    • When using this product do not use in ears or mouth
    • Avoid contact with eyes
    • In case of eye contact, rinse eyes thoroughly with water
  • STOP USE

    • Stop use and ask a doctor if skin irritation or redness develops and persists for more than 72 hours
  • INACTIVE INGREDIENT

    • Water,1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, C12-C15 Pareth-3, Polyaminopropyl biguanide, Caprylyl glucoside, Citronellol, Sorbic Acid, Glycerin, Aloe Barbadensis (Aloe) Leaf Extract, and  D and C Green No.5
  • PRINCIPAL DISPLAY PANEL

    GFS_FOAM
  • INGREDIENTS AND APPEARANCE
    GFS BIOPROTECT HAND SANITIZER ALOE VERA 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76426-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.0013 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    SORBIC ACID (UNII: X045WJ989B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76426-010-0128 g in 1 BOTTLE, PUMP
    2NDC:76426-010-0255 g in 1 BOTTLE, PUMP
    3NDC:76426-010-03110 g in 1 BOTTLE, PUMP
    4NDC:76426-010-04225 g in 1 BOTTLE, PUMP
    5NDC:76426-010-051000 g in 1 BOTTLE
    6NDC:76426-010-063790 g in 1 BOTTLE
    7NDC:76426-010-07204300 g in 1 DRUM
    8NDC:76426-010-082204600 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    9NDC:76426-010-09800 g in 1 BAG
    10NDC:76426-010-101200 g in 1 BAG
    11NDC:76426-010-111800 g in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/20/2011
    Labeler - GFS US LLC (967789228)
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