Label: HANDSOAP- chloroxylenol gel

  • NDC Code(s): 47993-324-01
  • Packager: NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD
  • 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, 2021

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  • ACTIVE INGREDIENT

    Active ingredients

    Chloroxylenol 0.3%

  • PURPOSE

    Antibacterial

  • INDICATIONS & USAGE

    Uses：

    • For hand sanitizing to reduce bacteria on the skin. 
  • WARNINGS

    Warnings:

    • For external use only.
  • WHEN USING

    When using this product

    • avoid contact with eyes.
    • if contact occurs,thoroughly rinse with water.
  • STOP USE

    Stop use and ask a doctor if

    • irritation or redness develops.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed,get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:

    • apply to wet hands and lather for at least 30 seconds.
    • wash,rinse and dry thoroughly.
    • To refill a small sized bottle,pour as needed.
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, GLYCERIN, COCAMIDE METHYL MEA, SODIUM CHLORIDE, FRAGRANCE, DMDM HYDANTION, CITRIC ACID, DISODIUM EDTA, DYE.

  • PRINCIPAL DISPLAY PANEL

    image of hand sanitizer 500ml-1image of hand sanitizer 500ml-2image of hand sanitizer 500ml-3image of hand sanitizer 500ml-4

  • INGREDIENTS AND APPEARANCE
    HANDSOAP 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-324-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/07/2021
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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