Label: ANTIBACTERIAL HANDSOAP WITH MOISTURIZER- chloroxylenol gel

  • NDC Code(s): 47993-277-01, 47993-277-02, 47993-277-03
  • Packager: NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD
  • Category: HUMAN OTC DRUG LABEL

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 November 5, 2020

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  • ACTIVE INGREDIENT

    Active ingredients

    Chloroxylenol 0.3%

  • PURPOSE

    Antibacterial

  • INDICATIONS & USAGE

    Uses：

    For hanbwashing to decrease bacteria on the skin.

  • WARNINGS

    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 doctorif irritation or redness develops.

    Keep out of reach of children. If swallowed，get medical help or contact a Poison Control Center right away.

  • WHEN USING

    When using this product avoid contact with eyes. In case of eye contact, flush 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 onto wet hands, lather for at least 30 second and rinse thoroughly.
    • To refill a small size bottle, pour as needed.
  • OTHER SAFETY INFORMATION

    Other information:

    • Avoid freezing and excessive heat above 40℃(104℉).
  • INACTIVE INGREDIENT

    Inactive Ingredients:

    WATER, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, GLYCERIN, COCAMIDE METHYL MEA, SODIUM CHLORIDE, PARFUM, CITRIC ACID, DISODIUM EDTA, METHYLCHLOROISOTHIAZOLINONE, METHYLISOTHIAZOLINONE, DYE.

  • PRINCIPAL DISPLAY PANEL

    image of Hand Sanitizer 5image of Hand Sanitizer 4image of Hand Sanitizer 3image of Hand Sanitizer 2image of Hand Sanitizer 1image of Hand Sanitizer 0

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HANDSOAP WITH MOISTURIZER 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-277
    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)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-277-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/2020
    2NDC:47993-277-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/17/2020
    3NDC:47993-277-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/17/2020
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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