Label: SOFTIE SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL WHITE TEA- 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 January 26, 2021

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    • For handwashing to decrease bacteria on the skin

  • WARNINGS: FOR EXTERNAL USE ONLY.

    Avoid contact with eyes, if eye contact occurs, flush with water.

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

    KEEP OUT OF REACH OF CHILDREN.

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

  • DIRECTIONS:

    Pump into hands, lather vigorously for at least 15 seconds, rinse and dry thoroughly.

  • Inactive ingredients

    Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Coco-Glucoside (and) Glyceryl Oleate, Cocamide DEA (and) Glycerin, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Parfum, Citronellol, Linalool.

  • SPL UNCLASSIFIED SECTION

    New!

    Softsoap® is a registered trademark of Colgate-Palmolive Co. which has not manufactured, distributed or sponsored this product.

    FDA APPROVED

    Designed & Developed
    By: Primax USA LLC
    Brooklyn, NY 11204

    MADE IN TURKEY

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SOFTIE SOFT AND SMOOTH HANDSOAP ANTIBACTERIAL WHITE TEA 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74955-054
    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)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74955-054-01400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/01/2021
    Labeler - COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI (595671824)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMOLIVE KOZMETIK SANAYI VE TICARET ANONIM SIRKETI595671824manufacture(74955-054)
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