Label: NO-GERMS HAND SANITIZER- benzalkonium chloride liquid

  • 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 July 16, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic Sanitizer

  • Use

    For hand sanitizing to help reduce bacteria on skin. Recommended for repeated use.

  • Warnings

    For external use only. Do not spray in the eyes.

    • When using this product, avoid contact with eyes. In case of contact, flush eyes with water.
    • Stop use and ask a doctor if redness or irritation occurs and persist for more than 72 hours
    • KEEP OUT OF REACH OF CHILDREN
  • KEEP OUT OF REACH OF CHILDREN

    Children should be supervised when using this product.

  • Directions

    Directions

    Read the entire label before using this product.

    Apply liberally to the hands and rub together until dry.

  • Inactive Ingredients

    Aqua, Glycerin, Citric Acid, Matricaria (Chamomilla Recutita) Flower Extract, Lavender (Lavandula Angustifolia) Extract, Aloe Barbadensis Leaf Juice

  • 25 ml NDC 79851-019-01

    25 ml label

  • 4 L NDC 79851-019-05

    4 L label

  • 50 ml NDC 79851-019-03

    50 ml label

  • 210 ml NDC 79851-019-09

    210 ml label

  • INGREDIENTS AND APPEARANCE
    NO-GERMS HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79851-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79851-019-0824 in 1 CASE08/26/2020
    1NDC:79851-019-0712 in 1 CASE
    1NDC:79851-019-0125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:79851-019-0612 in 1 CASE08/26/2020
    2NDC:79851-019-0350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:79851-019-04210 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/26/2020
    4NDC:79851-019-054000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/26/2020
    Labeler - Millennium Research USA LLC (110101867)
    Establishment
    NameAddressID/FEIBusiness Operations
    Millennium Research Llc110101867manufacture(79851-019) , pack(79851-019) , label(79851-019)
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