Label: REGESI BEST LIFE ALCOHOL FREE FOAMING HAND DISINFECTANT- benzalkonium chloride solution

  • 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 April 14, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Fact

  • Active Ingredient(s)

    BENZALKONIUM CHLORIDE: 0.13%

  • Purpose

    Antiseptic

  • Use

    Use: Sterilization of surgical hands, sanitary hands, and disinfection of other parts

  • Warnings

    Warning:

    For external use only. 

    Do not apply around eyes, do not use in ears and mouth. In case of contact rinse with water

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Chidren must be supervised in use of this product

  • DOSAGE & ADMINISTRATION

    Directions: 

    Pump to hands and rub into skin untill dry

  • Inactive ingredients

    Inactive Ingredients: Aloe Vera Extract, Water, soybean extract, calcium sodium phophosilicate extract, Betane, cocoamidopropylbetaine

  • STORAGE AND HANDLING

    Storage: Store in cool dry place away from light at room temperature

  • Package Label - Principal Display Panel

    image description

  • INGREDIENTS AND APPEARANCE
    REGESI BEST LIFE ALCOHOL FREE FOAMING HAND DISINFECTANT 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74684-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN (UNII: L7HT8F1ZOD)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM SODIUM PHOSPHATE (UNII: 7850XT8YDT)  
    BETAINE (UNII: 3SCV180C9W)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74684-002-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product04/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/08/2020
    Labeler - Beijing Best Life Regenerative Medicine Technology Co. Ltd. (414547267)
    Establishment
    NameAddressID/FEIBusiness Operations
    Beijing Best Life Regenerative Medicine Technology Co. Ltd.414547267manufacture(74684-002)
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