Label: GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES- 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 January 3, 2023

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  • Active Ingredient

    Benzalkhonium Chloride 0.12%

    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 thoroughly with water.

    Discontinue use if

    irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

    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

    • Store below 95° F (35° C) to prevent from drying out.

    • Dispose of wipe in the proper container.

    • Do not flush down the toilet.

  • Inactive ingredients

    Aqua (Purified & De-Ionized Water), Aloe Barbadensis Leaf Extract, Citric Acid, Didecyldimonium Chloride, 2-Bromo-2-Nitropropane-1,3-Diol, Polyaminopropyl Biguanide, Parfum (Fragrance).

  • Package Labeling:

    image description

  • INGREDIENTS AND APPEARANCE
    GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70335-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    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:70335-301-088 in 1 PACKAGE09/06/201611/30/2025
    130 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/06/201611/30/2025
    Labeler - Innovent Inc. (079973489)
    Registrant - American Hygienics Corporation (545198454)
    Establishment
    NameAddressID/FEIBusiness Operations
    American Hygienics Corporation545198454manufacture(70335-301)
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