Label: BENZOCLEAN HAND SANITIZER- 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 July 11, 2020

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use ▪ For handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings For external use only. Do not use ▪ in the eyes Stop use and ask a doctor if ▪ irritation and redness develop ▪ if condition persists for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions ▪ Place enough product in your palm to thoroughly cover your hands. ▪ Rub hands together briskly until dry. ▪ No rinsing required. No towels needed.

  • STORAGE AND HANDLING

    Other information Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredients Water (Aqua), Aloe Barbadensis Leaf Juice, Disodium EDTA, DMDM Hydantoin, Fragrance, Glycerin, Hydroxyethylcellulose, Sodium Chloride, Tocopheryl Acetate.

  • SPL UNCLASSIFIED SECTION

    ADVANCED

    MOISTURIZING 

    LONG-LASTING GEL

    WITH ALOE VERA & VITAMIN E

    KILLS 99.9% OF GERMS

    *Kills Most Viruses

    *Moisturizes & Leaves

    Hands Feeling Smooth

    MADE IN THE USA

    GMP GOOD MANUFACTURING PRACTICE QUALITY PRODUCT 

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

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    BENZOCLEAN HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53113-090-08236.5 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - GADAL Laboratories, Inc (841305639)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639manufacture(53113-090)
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