Label: FOAMING ANTIBACTERIAL GREEN- antibacterial green liquid

  • 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 December 30, 2021

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  • SPL UNCLASSIFIED SECTION

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

    1. Isopropyl Alcohol (3%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Chloroxylenol (0.5% w/v).
    3. Sodium Laureth Sulfate (6% v/v).
    4. Cocamidopropyl Betaine (2% v/v).
    5. Decyl Glucoside (1% v/v)
    6. Sodium C14-16 Olefin Sulfonate (2% v/v)
    7. DMDM Hydantoin (0.3% v/v)
    8. Citric Acid (0.015% v/v)
    9. PEG-40 Hydrogenated castor oil (0.2% v/v)
    10. Sterile distilled water or boiled cold water.

    The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

  • Active Ingredient(s)

    Chloroxylenol 0.5% w/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Sodium Laureth Sulfate, Isopropyl Alcohol, Cocamidopropyl Betaine, Decyl Glucoside, Sodium C14-16 Olefin Sulfonate, DMDM Hydantoin, Citric Acid, PEG-40 Hydrogenated castor oil, FD&C Blue NO.1, FD&C Yellow NO.5,purified water USP

  • Package Label - Principal Display Panel

    labeling information1000 ml NDC: 80401-110-10

  • INGREDIENTS AND APPEARANCE
    FOAMING ANTIBACTERIAL GREEN 
    antibacterial green liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80401-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) 2 mL  in 100 mL
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 6 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302) 3 mL  in 100 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 2 mL  in 100 mL
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 1 mL  in 100 mL
    CHLOROCITRIC ACID (UNII: 0W1BY8O77G) 0.015 mL  in 100 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.2 mL  in 100 mL
    DMDM HYDANTOIN (UNII: BYR0546TOW) 0.3 mL  in 100 mL
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80401-110-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/30/2020
    Labeler - Uweport LLC (081252924)
    Registrant - uweport (081252924)
    Establishment
    NameAddressID/FEIBusiness Operations
    Uweport llc081252924label(80401-110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Bolicen Bio-Technology Co Ltd554525110manufacture(80401-110)
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