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 October 28, 2020

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  • Drug Facts

  • Active ingredient[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.

  • Inactive ingredients

    Water, Calcium Silicate

  • SPL UNCLASSIFIED SECTION

    Kills 99.99% of Bacteria & Viruses

    4-HR HAND SANITIZER

    • NON-FLAMMABLE

    • NON-TOXIC

    • DYE FREE

    • FRAGRANCE FREE

    MADE IN THE USA

    Manufactured By:

    Guide Solutions
    9330 S. Highway 99
    Prague, OK 74864
    405-567-0710

    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:77042-110
    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:77042-110-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    2NDC:77042-110-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    3NDC:77042-110-013785 mL in 1 JUG; 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 - Guide Energy Solutions LLC (117045830)
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