Label: PROTECT U GUARD FOAMING HAND SANITIZER ALCOHOL FREE- 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 November 6, 2017

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  • Active Ingredients

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    For hand sanitizing to decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

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

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

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    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 your palm to cover all surfaces of hands completely.

    Rub hnads together until dry.

    Supervise children in the use of this product.

  • Inactive Ingredients

    Water, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocate, Citric Acid

  • Questions or comments?

    1-813-815-0530 or www.protectuguard.com

  • PRINCIPAL DISPLAY PANEL

    18 Ounce Label1000 ML Front1000 ML Back

  • INGREDIENTS AND APPEARANCE
    PROTECT U GUARD FOAMING HAND SANITIZER ALCOHOL FREE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71788-234
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71788-234-606 in 1 CARTON11/06/2017
    1NDC:71788-234-50530 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71788-234-204 in 1 CARTON11/06/2017
    2NDC:71788-234-101000 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/06/2017
    Labeler - Protect U Guard, LLC (080070945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aire-Master of America, Inc057897381manufacture(71788-234)
    Establishment
    NameAddressID/FEIBusiness Operations
    Protect U Guard, LLC080070945relabel(71788-234)
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