Label: ANTIMICROBIALSOAP- chloroxylenol gel

  • NDC Code(s): 47993-325-01, 47993-325-02, 47993-325-03, 47993-325-04
  • 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 17, 2021

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  • ACTIVE INGREDIENT

    Active ingredients

    Chloroxylenol 0.75% w/w

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Uses：

    • for hand-washing to decrease microbes on the skin.
    • ideal for daily repeated washing
  • WARNINGS

    Warnings:

    For external use only.

  • WHEN USING

    When using this product

    • do not use in or near eyes.
  • STOP USE

    • discotinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions:

    • wet hands
    • apply product (palmful)
    • wash hands vigorously
    • rinse thoroughly
  • OTHER SAFETY INFORMATION

    Other information:

    • store at room temperature
    • for healthcare professional use only
  • INACTIVE INGREDIENT

    Inactive ingredients:

    Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Coconut Fatty Acid, D&C Green No.8, FD&C Blue No.1, FD&C Yellow No.5, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Monoethanolamine, Oleic Acid, Propylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Water.

  • PRINCIPAL DISPLAY PANEL

    image of hand sanitizer 532mlimage of hand sanitizer 3800mlimage of hand sanitizer 800mlimage of hand sanitizer 118ml

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIALSOAP 
    chloroxylenol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47993-325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    D&C GREEN NO. 8 (UNII: I2W85YOX9L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47993-325-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2021
    2NDC:47993-325-02532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/15/2021
    3NDC:47993-325-03800 mL in 1 BAG; Type 0: Not a Combination Product06/15/2021
    4NDC:47993-325-043800 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2021
    Labeler - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
    Registrant - NINGBO JIANGBEI OCEAN STAR TRADING CO.,LTD (529334491)
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