Label: JINGLINZI ETHANOL DISINFECTANT- ethanol liquid

  • NDC Code(s): 83179-001-01
  • Packager: Shaoyang Jinglinzi Biotechnology 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 February 13, 2023

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  • ACTIVE INGREDIENT

    ethanol 65%-75% v/v. Purpose: Antiseptic

    hydrogen peroxide 3600mg/L-4400mg/L Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.It can kill intestinal pathogenic bacteria, suppurative coccus, common bacteria of hospital infection and phthogeic yeast, and inactivate poliovirus and SARS-CoV-2

  • 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.

  • DOSAGE & ADMINISTRATION

    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.

  • STORAGE AND HANDLING

    Protect from light, seal, moisture, fire, and store in a cool and dry place

  • INACTIVE INGREDIENT

    water

  • PRINCIPAL DISPLAY PANEL

    500 mL NDC: 83179-001-01 500ML

  • INGREDIENTS AND APPEARANCE
    JINGLINZI ETHANOL DISINFECTANT 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83179-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE400 mg  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 30 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83179-001-01500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/14/2023
    Labeler - Shaoyang Jinglinzi Biotechnology Co., Ltd (842322204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoyang Jinglinzi Biotechnology Co., Ltd842322204manufacture(83179-001)
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