Label: ALCOHOL FREE HAND SANITIZER- benzalkonium chloride liquid

  • 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 5, 2021

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

  • Drug Facts

  • Active ingredients[s]

    Benzalkonium Chloride 0.13%

  • Purpose

    Skin Antiseptic

  • Use[s]

    For hand and skin sanitizing to decrease microbes on skin.

  • Warnings

    For external use only. Do not use in the eyes. In case of eye contact, flush thoroughly with water & seek medical attention.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

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

  • Directions

    Dispense an adequate amount in palm to cover hands. 

    Rub hands together to cover skin thoroughly until dry.

    Supervise young children while using this product.

  • Other information

    *Skin cells may be shed naturally or by abrasion prior to 4 hours, exposing fresh, unprotected skin. Reapply as needed. Do not allow product to freeze.

  • Inactive ingredients

    Water, Calcium Silicate

  • SPL UNCLASSIFIED SECTION

    Kills 99.99% of Bacteria & Viruses

    By DevbondUSA

    4-HOUR HAND SANITIZER

    NON-FLAMMABLE

    NON-TOXIC

    DYE FREE

    FRAGRANCE FREE

    UltraNanoClean Hand Sanitizer has proven residual antimicrobial benefits for up to four hours. It's active ingredient is a preferred skin antiseptic that kills germs on contacts and inhibits future microbial growth. In addition, the proprietary mineral blend enhances product bonding and long lasting effectiveness.

    Kills 99.9% of illness-causing germs on contact & persists on skin for up to 4 hours

    Alcohol Free,  Foaming Formula won't dry hands, sting or cause cracking

    Moisture-infused foam leaves skin feeling nourished & silky, even after repeated applications

    Outperforms alcohol-based sanitizers by persisting on skin; guarding against exposure

    MADE IN THE USA

    Distributed by:

    DevBond USA

    1836 Augusta Drive

    Suite 16

    Houston TX 77057

    (713) 256-6160

    FOR EXTERNAL USE ONLY

    FDA Registered

  • Packaging

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  • INGREDIENTS AND APPEARANCE
    ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79993-110
    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)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79993-110-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
    2NDC:79993-110-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2021
    3NDC:79993-110-013785 mL in 1 JUG; Type 0: Not a Combination Product08/01/2020
    4NDC:79993-110-0518927 mL in 1 PAIL; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - Devbond Consulting, L.l.c (023344086)