Label: BANITORE ALCOHOL HAND RUB- alcohol 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 March 9, 2022

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  • Active Ingredient(s)

    Ethanol 80% v/v

  • Purpose

    Antiseptic

  • Use

    • Hand Rub 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.
  • STOP USE

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

  • Do not use

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

  • Other information

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

    purified water, glycerin, hydrogen peroxide.

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes througthly with water.

  • Package Label - Principal Display Panel

    500ml label 500mL NDC: 56084-031-01

  • INGREDIENTS AND APPEARANCE
    BANITORE ALCOHOL HAND RUB 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56084-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56084-031-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/05/2022
    Labeler - Zhejiang RIFESHOW Cosmetics Co., Ltd. (560843477)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang RIFESHOW Cosmetics Co., Ltd.560843477manufacture(56084-031)
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