Label: TRICLOSAN FREE ANTIBACTERIAL ANTIBACTERIAL- chloroxylenol liquid

  • NDC Code(s): 58503-100-01
  • Packager: China Ningbo Shangge Cosmetic Technology Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 18, 2019

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  • PURPOSE

    Purpose

    Antibacterial

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  • ACTIVE INGREDIENT

    Active Ingredient

    Chloroexylenol, 0.3%

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  • INDICATIONS & USAGE

    USAGE

    For hand washing to decrease bacteria on the skin

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  • DOSAGE & ADMINISTRATION

    Directions

    Pump into hands

    Lather vigorously for at least 15 seconds

    Rinse and dry thoroughly

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  • 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.

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  • 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 doctor if irritation and redness develops

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  • INACTIVE INGREDIENT

    WATER, SODIUM LAURETH SULFATE, COCAMIDE MEA, SODIUM C14-16 OLEFIN SULFONATE, SODIUM CHLORIDE, PEG-150 DISTEARATE, FRAGRANCE, CITRIC ACID, GLYCERIN, PEG-40 HYDROGENATED CASTOR OIL, DISODIUM EDTA, TOCOPHERYL ACETATE, METHYLCHLOROTHIAZOLINONE, METHYLISOTHIAZOLINONE, FD&C YELLOW NO.5, D&C RED NO. 33

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  • INGREDIENTS AND APPEARANCE
    TRICLOSAN FREE ANTIBACTERIAL  ANTIBACTERIAL
    chloroxylenol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-100
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58503-100-01 443 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/25/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 04/25/2017
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    Name Address ID/FEI Business Operations
    China Ningbo Shangge Cosmetic Technology Corp. 529287434 manufacture(58503-100)
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