Label: GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth

  • NDC Code(s): 70335-304-00, 70335-304-01
  • Packager: Innovent Inc
  • 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 January 3, 2023

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  • Drugs Fact

  • Active ingredient

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • Uses:

    Decrease bacteria on the skin.

  • Warnings

    • For external use only.

    When using this product 

    • avoid contact with eyes. If contact occurs, rinse thorughly with water.

    Do not use 

    • if irritation and redness develop.

    Stop use and ask a doctor 

    • if condition persists for more than 72 hours.

    Keep out of reach of children.

    • If swallowed, get medical help or contact Poison Control Center right away.
  • Directions

    • Open resealable label, remove one wipe to use.
    • Wipe hands thoroughly with product and allow to dry without wiping.
    • Close resealable label after use to retain moisture.
  • Other information

    • Dispose of wipe in the proper container.
    • Do not flush down the toilet.
  • Inactive ingredients

    2-Bromo-2-Nitropropane-1,3-Diol, Alcohol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Fragrance, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Water.

  • Package Labeling:

    Label

  • Package Labeling: 50Ct

    Tube

  • INGREDIENTS AND APPEARANCE
    GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70335-304
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70335-304-001 in 1 BOX04/15/202011/30/2025
    125 in 1 PACKAGE
    14 mL in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:70335-304-011 in 1 BOX06/15/202011/30/2025
    250 in 1 PACKAGE
    24 mL in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/15/202011/30/2025
    Labeler - Innovent Inc (079973489)
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