Label: SAFEGUARD  ANTIBACTERIAL FOAMING- benzalkonium chloride soap 

  • NDC Code(s): 37000-601-40
  • Packager: Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/10

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Benzalkonium Chloride 0.12%

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  • Purpose

    Antiseptic Hand Cleanser

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  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use
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  • Warnings

    • For external use only

    When using this product

    • Do not use in or near eyes

    • Discontinue use if irritation and redness develop

    Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

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  • Directions

    • Wet hands and forearms
    • Apply enough product to adequately cover the entire surfaces of the hands and forearms
    • Scrub thoroughly for at least 30 seconds (include the fingernails and the cuticles)
    • Rinse
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  • Other information

    • Store in a cool dry place below 104° F
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  • Inactive ingredients

    Water, glycerine, cocoamidopropyl betaine, polyoxypropylene-polyoxyethylene block copolymer, benzyl alcohol, fragrance, phenoxyethanol, tetra sodium EDTA, dehydroacetic acid, FD&C Red #4, FD&C Yellow #5

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  • Questions?

    Contact Procter & Gamble Professional® Mon-Fri 9am - 5pm EST at 1-800-332-7787

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  • PRINCIPAL DISPLAY PANEL - 1.2 L Bag Label

    Procter & Gamble
    Professional®

    Safeguard®
    AntiBacterial

    Foaming Hand Soap
    Benzalkonium Chloride Foaming Antibacterial Hand Soap

    1.2L (1.26 QT) 40.5 FL OZ

    Principal Display Panel - 1.2 L Bag Label
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  • INGREDIENTS AND APPEARANCE
    SAFEGUARD   ANTIBACTERIAL FOAMING
    benzalkonium chloride soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-601
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzalkonium Chloride (Benzalkonium) Benzalkonium Chloride 0.12 g  in 100 mL
    Product Characteristics
    Color ORANGE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-601-40 1200 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333E 07/01/2010
    Labeler - Procter & Gamble Manufacturing Company (004238200)
    Establishment
    Name Address ID/FEI Business Operations
    Best Sanitizers, Inc. 627278224 ANALYSIS, MANUFACTURE, RELABEL, REPACK
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