Label: NEW HANSAN HAND SANITIZER 500ML- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 15, 2020

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: ALCOHOL 70.0%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    Water, Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Triethanolamine, Calendula Officinalis Extract, Flavor

  • PURPOSE

    PURPOSE: SANITIZER

  • 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.

  • Uses:

    Uses : Hand sanitizer to help reduce bacteria on the skin.

  • WARNINGS

    Warnings:

    Flammable. Keep away from fire or flame.
    For external use only.
    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions:

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.

  • Other Information

    Other Information:
    • Store below 90°F(32°C)
    • May discolor certain fabrics or surfaces

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    NEW HANSAN HAND SANITIZER 500ML 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74080-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350.0 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Trolamine (UNII: 9O3K93S3TK)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74080-040-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - Bb & Co., Ltd. (695732817)
    Registrant - Bb & Co., Ltd. (695732817)
    Establishment
    NameAddressID/FEIBusiness Operations
    KMPHARMACEUTICAL Co.,Ltd.688679158manufacture(74080-040)
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