Label: CLEANPHIRST ALCOHOL FREE ANTISEPTIC HAND SANITIZER- benzalkonium chloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 1, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                                              Purpose

    Benzalkonium Chloride 0.13 percent.............................Antiseptic

  • PURPOSE

    Uses

    For hand washing to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings:

    For external use only.

    Do not use in the eyes.

    Discontinue if irritation or redness develop.

    If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Wet hands thoroughly with product and allow to dry without wiping.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Behentrimonium Chloride, Citric Acid, Dihydroxyethyl Cocamine Oxide, Dihydroxpropyl PEG-5, Linoleammonium Chloride, Fragrance, Glycereth-2 Cocoate, Glycerin, Potassium Carbonate, Water.
  • PRINCIPAL DISPLAY PANEL

    sanitizerdrugpanel

  • PRINCIPAL DISPLAY PANEL

    CLEANpHIRST

    Alcohol Free

    Antiseptic Hand Sanitizer

    Kills up to 99.999 percent of germs

     leaves skin soft

    Won't Dry Out Hands

    www.cleanphirst.com

    125 Applications/1.7fl oz (50mL)

     Manufactured by: MicroPure Solutions, LLC

    1055 Stevenson Ct., Suite 15 W

     Roselle, IL 60172

    United States   

    Exp. Date:

     Lot No.:
  • PRINCIPAL DISPLAY PANEL

    cleanphirstsanitizer1

  • INGREDIENTS AND APPEARANCE
    CLEANPHIRST ALCOHOL FREE ANTISEPTIC HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52138-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CARBONATE (UNII: BQN1B9B9HA)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52138-100-5050 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/12/2010
    Labeler - Cleanphirst, LLC (833241438)
    Establishment
    NameAddressID/FEIBusiness Operations
    MicroPure Solutions, LLC805764508manufacture
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