Label: ATERRA7 ANTIBACTERIAL FOAMING HAND- benzalkonium chloride soap

  • NDC Code(s): 68306-115-01, 68306-115-02, 68306-115-03
  • Packager: B4 Ventures LLC
  • 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 September 20, 2019

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  • ​Active Ingredient

       Benzalkonium Chloride 0.1%

  • ​Purpose

    Skin Antimicrobial

  • ​Use

    reduces amount of bacteria on hands

  • ​Warnings

    ​For external use only​.

    ​When using this product​ avoid contact with eyes.  In case of eye contact, flush eyes with water.

    ​Stop use and ask a doctor if​ irritation or redness develops, or if condition persists for more than 72 hours.

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

  • ​Directions

    • Apply a palmful to hands and forearms.
    • Scrub thoroughly for at least 15 seconds.
    • Rinse completely and dry.
  • ​Inactive Ingredients

    Water, Lauramine Oxide, Glycerin, PEG-120 Methyl Glucose Dioleate, Fragrance

  • PRINCIPAL DISPLAY PANEL

    18 fl. oz. Label

  • INGREDIENTS AND APPEARANCE
    ATERRA7 ANTIBACTERIAL FOAMING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68306-115
    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
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    Product Characteristics
    Colorwhite (water white, colorless (dispensed as white foam)) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68306-115-01530 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/26/2018
    2NDC:68306-115-024 in 1 BOX09/26/2018
    21000 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:68306-115-034 in 1 BOX09/20/2019
    31000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/26/2018
    Labeler - B4 Ventures LLC (133582853)