Label: SOFT CARE SENTRY- benzalkonium chloride solution

  • 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 March 1, 2018

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  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    For hands to decrease bacteria on the skin.

    Recommended for repeated use.

  • WARNINGS

    Warnings

    For external use only.

    Do not ingest

    Do not use in the eyes.

    When using this product do not get in eyes.

    In case of contact, immediately flush with water.

    Stop use and ask a doctor if irritation and 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.

    Do not use if you are allergic to any ingredients.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply a small amount to hands, add water and lather by rubbing hands together for 20 seconds, rinse with potable water.

  • REFERENCES

    Other information

    EMERGENCY PHONE: 1-800-851-7145

    See SDS MS0801277

    FOR COMMERCIAL USE

    See container for Lot Code and Expiry Date.

    Store in a cool dry place.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Cocamidopropyl betaine, Cocamidopropyl PG-Dimmonium Chloride Phosphate, Laurtrimonium Chloride, PEG-6 Cocamide, Iodopropynyl Butylcarbamate, Methylisothiazolinone

  • QUESTIONS

    Questions or comments?

    1-800-558-2332 Monday through Friday 7:30 AM to 5:00 PM Central Standard Time

    www.diversey.com

  • PRINCIPAL DISPLAY PANEL

    Diversey

    NDC 64536-1948-3

    Soft Care Sentry

    Foaming Antibacterial Hand Soap

    For commercial use

    NSF

    Nonfood Compounds

    Program Listed E2

    Registration 156691

    (L)     Exp.

    Net Contents

    1.3 L / 1.37 U.S. Qt.

    SKU: 101100320

    container labelFPM1

    container labelBPM3



  • INGREDIENTS AND APPEARANCE
    SOFT CARE SENTRY 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64536-1948
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64536-1948-31300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/19/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/19/2018
    Labeler - Diversey, Inc. (018240817)
    Establishment
    NameAddressID/FEIBusiness Operations
    KUTOL PRODUCTS COMPANY004236139manufacture(64536-1948)
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