Label: PANROSA ANTIBACTERIAL HAND ROSE- chloroxylenol gel

  • 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 August 13, 2020

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  • Drug Facts

  • Active ingredient

    Chloroxylenol 0.25%

    Purpose

    Antibacterial

  • Uses

    • for hand washing 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.

    If pregnant or breast-feeding,

    ask a health professional before use

    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 least 15 seconds
    • wash skin, rinse and dry thoroughly
  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, Glycerin, Glycol Stearate, Sodium Chloride, PEG-150 Distearate, Citric Acid, Fragrance, Methylisothiazolinone, Methylchloroisothiazolinone, Disodium EDTA, D&C Red NO. 33 FD&C Red No.4.

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    PANROSA ANTIBACTERIAL HAND ROSE 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50302-016
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50302-016-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - Panrosa Enterprises, Inc. (859957578)
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