Label: GFS BIOPROTECT HAND SANITIZER ALOE VERA- benzalkonium chloride 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 3, 2013

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

View All Sections
  • DESCRIPTION

    BioProtect Hand Sanitizer contains 0.13% antiseptic agent Benzalkonium Chloride formulated with Water,Hydroxyethyl Cellulose, Alkyl Polyglucoside, C12-C15 Pareth-3, 1-Ocatadecanaminium, N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride, Polyhexamethylene
    Biguanide, Acetic Acid, Citronellol, Ammonia, 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

    • Antiseptic
  • 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; Hydroxyethyl Cellulose; Alkyl Polyglucoside; C12-C15 Pareth-3; 1-Ocatadecanaminium,N-N-dimethyl-N-[3-(trimethoxysilyl)propyl]-,chloride; Polyhexamethylene Biguanide; Acetic Acid; Citronellol; Ammonia; Glycerin; AloeBarbadensis (Aloe) Leaf Extract;  D and C Green No.5
  • PRINCIPAL DISPLAY PANEL

    LabelBP_GEL

  • INGREDIENTS AND APPEARANCE
    GFS BIOPROTECT HAND SANITIZER ALOE VERA 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76426-012
    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)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
    Acetic Acid (UNII: Q40Q9N063P)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    AMMONIA (UNII: 5138Q19F1X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76426-012-0150 g in 1 BOTTLE, DISPENSING
    2NDC:76426-012-02250 g in 1 BOTTLE, PUMP
    3NDC:76426-012-031000 g in 1 BOTTLE
    4NDC:76426-012-043790 g in 1 BOTTLE
    5NDC:76426-012-05204116 g in 1 DRUM
    6NDC:76426-012-06997903 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/26/2011
    Labeler - GFS US LLC (967789228)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!