Label: CERBERUS ALCOHOL-FREE HAND SANITIZER- 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 December 7, 2020

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

View All Sections
  • Active Ingredient(s)

    Alcohol 0.13% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Do not use in eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask doctor if skin irritation develops.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Citric acid, glycerin, lemongrass oil, water

  • Package Label - Principal Display Panel

    473 mL NDC: 80892-005-16

    473ml

    3785 ml NDC: 80892-005-01

    3785 mL

  • INGREDIENTS AND APPEARANCE
    CERBERUS ALCOHOL-FREE HAND SANITIZER 
    benzalkonium chloride aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80892-005
    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
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80892-005-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/07/2020
    2NDC:80892-005-013785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/07/2020
    Labeler - GLOBAL CO PAK LLC (117638624)
    Registrant - CERBERUS CRAFT DISTILLERY LLC (004160750)
    Establishment
    NameAddressID/FEIBusiness Operations
    Environmental Manufacturing Solutions, LLC031863249manufacture(80892-005)
    Establishment
    NameAddressID/FEIBusiness Operations
    GLOBAL CO PAK LLC117638624relabel(80892-005)
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!