Label: ADVANCED HAND 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 June 5, 2020

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  • Active Ingredient(s)

    alcohol

  • Purpose

    Purpose: Antiseptic

  • Use

     Hand sanitizing to help reduce bacteria on the skin

  • Warnings

    For external use only.
    when using this product, avoid contact with the eyes. In case of contact, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or redness appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

     Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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.

  • INACTIVE INGREDIENT

    Water

    Glycern

    Phenoxyethanol

    Cabomer

    Triethanolamine

    Butylene Glycol

    1,2-Hexanediol

    OpuntiaFicus-Indica Extract

    Bambusa Vulgaris Leaf/Stem Extact

    AvenaSativa(oat)kemel Ext

    Luffa Cylindrica Fruit Ext

    Aloe Barbadensis Leaf Ext

    Salvia Hispanica Seed Ext

    Cocos Nucifera(Coconut)Fruit

    ButyrospermumParkil(Shea)Butter Ext

    scutellariaBaicalensis Ext

    LaminariaJaponica Ext

    Ethylhexylglycerin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78761-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78761-0001-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/05/2020
    Labeler - Bonange Korea Inc (695520624)
    Registrant - Bonange Korea Inc (695520624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bonange Korea Inc695520624manufacture(78761-0001)
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