Label: BIOPROTECT ALCOHOL FREE HAND SANITIZER- benzalkonium chloride spray

  • 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 August 19, 2020

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  • DRUG FACTS

  • Active Ingredient:

    Benzalkonium Chloride 0.13%

    Purpose:

    Antiseptic Hand Sanitizer

  • Uses:

    Hand Sanitizer to help decrease bacteria on the skin - Recommended for repeated use.

  • Warnings:

    Do not freeze.
    For external use only.
    Do not use in ears or mouth.

    When using this product,

    • avoid contact with the eyes. In case of contact, flush eyes 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.

    • Children should be supervised when using this product.
  • Directions:

    Apply a small amount into palms and spread on both hands. Rub into skin until dry

  • Inactive Ingredients:

    Water, Polyaminopropyl biguanide, 1-Octadecanaminum NN dimethyl(3-trimethoxysilyl) propyl chloride, C12-15 Pareth 12, Caprylyl Glucoside, Benzalkonium Chloride 50%, Sodium Benzoate, Glycerin, Aloe Barbadensis Leaf Juice Extract, Citronellol, Citric Acid, FD&C Blue No. 1

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    BIOPROTECT ALCOHOL FREE HAND SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79141-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    C12-15 PARETH-12 (UNII: 131316X18L)  
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79141-001-00236 mL in 1 CAN; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Global BioProtect, LLC (080387141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vin Mar Industries LLC114772616pack(79141-001)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRENNTAG MID-SOUTH, INC.122625064manufacture(79141-001)
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