Label: BNC HAND SANITIZER ANTISEPTIC- 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 1, 2020

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  • Active Ingredient

    Alcohol 80% v/v.

  • Purpose

    Antiseptic

  • Uses

    Hand Sanitizer 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

    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

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together briskly until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

    Other information

    Store between 15-300C (59-860F)
    Avoid freezing and excessive heat above 400C (1040F)

  • Inactive ingredients

    Aloe vera leaf, Butylene glycol, Carbomer, Glycerin, 1,2-hexanediol, Purified water USP, Trolamine

    Questions? CALL 213-462-9955

  • Package Label - Principal Display Panel

    Label 100 mL

    Label1

    Label 300 mL

    Label2

    Label 500 mL

    Label3

  • INGREDIENTS AND APPEARANCE
    BNC HAND SANITIZER ANTISEPTIC 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78419-002
    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)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78419-002-01100 mL in 1 TUBE; Type 0: Not a Combination Product06/01/2020
    2NDC:78419-002-02300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    3NDC:78419-002-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - BNC KOREA CO., Ltd. (694074732)
    Establishment
    NameAddressID/FEIBusiness Operations
    BNC KOREA CO., Ltd.694074732manufacture(78419-002)
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