Label: VI ZERO DOCTORS SANITIZER- alcohol gel

  • 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 May 29, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL 66.50% w/w

  • INACTIVE INGREDIENTS

    Water, Glycerin, Aloe Vera Gel, Mulberry Root Extract, Carbomer, Triethanolamine, Fragrance

  • PURPOSE

    Hand Sanitizer

  • 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 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.

  • Uses

    Instant hand sanitizer to reduce bacteria on the skin.

  • Directions

    • Apply product onto clean and dry hands.
    • Rub hands together covering all surfaces of hands and fingers until it is absorbed.
    • Children should be supervised when using.

  • Other information

    • Store between 1-30°C (34-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of tube

  • INGREDIENTS AND APPEARANCE
    VI ZERO DOCTORS SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78394-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33.25 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78394-010-0150 g in 1 TUBE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - HWAJIN BIO COSMETICS CO., LTD. (688012988)
    Registrant - HWAJIN BIO COSMETICS CO., LTD. (688012988)
    Establishment
    NameAddressID/FEIBusiness Operations
    HWAJIN BIO COSMETICS CO., LTD.688012988manufacture(78394-010)
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