HAND ANTIBACTERIAL (CHLOROXYLENOL) SOAP [PANROSA ENTERPRISES, INC.]

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HAND ANTIBACTERIAL (CHLOROXYLENOL) SOAP [PANROSA ENTERPRISES, INC.]
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NDC 50302-540-00, 50302-540-01
Set ID b7f953ce-1261-4534-9fe6-76dd56dd4180
Category HUMAN OTC DRUG LABEL
Packager PANROSA ENTERPRISES, INC.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.25%

    Purpose

    Antibacterial

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes. In case of eye contact, 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, wet as needed
    • lather vigorously for at leat 15 seconds
    • wash skin, rinse and dry thoroughly
  • Inactive Ingredients:

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, Sodium Chloride, Glycerin, Disodium EDTA, PEG-150 Distearate, Citric Acid, Fragrance (Parfum), Methylisothiazolinone, Methylchloroisothiazolinone, FD&C Yellow No. 5, FD&C Red No. 4.

  • Package Labeling:

    Package Label 500mLPackage Label 710mL

  • INGREDIENTS AND APPEARANCE
    HAND ANTIBACTERIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-540-00500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2016
    2NDC:50302-540-01710 mL in 1 BOTTLE; Type 0: Not a Combination Product05/20/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/20/2016
    Labeler - PANROSA ENTERPRISES, INC. (859957578)
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