Label: SOFT CARE DEFEND ANTIBACTERIAL HANDWASH- choroxylenol solution

  • NDC Code(s): 64536-8748-2, 64536-8748-3
  • Packager: Diversey, Inc.
  • 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 June 7, 2023

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  • ACTIVE INGREDIENT

    Active ingredient

    Chloroxylenol 1.0%

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    For handwashing to decrease bacteria on the skin.

    For occasional use.

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame.

    For external use only.

    Do not ingest

    Do not use in the eyes.

    When using this product do not get into the eyes.

    In case of eye contact, immediately flush with water.

    Stop use and ask a doctor if irritation and redness develop.

    If conditions 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

    Wet hands and forearms.

    Apply 0.4 mL or 1.0 mL of soap to hands.

    Lather hands and forearms for at least 30 seconds, rinse thoroughly with potable water.

    Supervise children when they use this product.


  • REFERENCES

    Other information

    EMERGENCY PHONE: 1-800-851-7145

    See SDS MS0301547

    FOR COMMERCIAL USE.

    See container for Lot Code and Expiry Date.

    Store in a cool dry place.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Ammonium Lauryl Sulfate, Alcohol Denat, Sodium Lauryl Ether Sulfate, Propylene Glycol, Hydroxyethyl cellulose, Tetrasodium EDTA, Isopropyl Alcohol

  • 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

    NDC 64536-8748-3

    DIN 02449420

    Diversey

    SoftCare Defend

    Antibacterial Handwash

    Chloroxylenol Liquid

    For commercial use

    U

    NSF

    Nonfood Compounds

    Program Listed E2

    Registration # 152963

    (L) Exp.

    Net Contents

    1.2 L/ 1.27 U.S. Qt.

    SKU: 100907901

    container label

    container label

  • INGREDIENTS AND APPEARANCE
    SOFT CARE DEFEND ANTIBACTERIAL HANDWASH 
    choroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64536-8748
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64536-8748-21200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2016
    2NDC:64536-8748-31200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/29/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/06/2016
    Labeler - Diversey, Inc. (018240817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diversey Canada, Inc.249266974manufacture(64536-8748)
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