Label: BLACK OPS AB ANTIBACTERIAL FOAMING- benzalkonium chloride soap

  • NDC Code(s): 79016-103-12
  • Packager: Archer Manufacturing, 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 September 23, 2023

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  • ACTIVE INGREDIENTS

    BENZALKONIUM CHLORIDE 0.13%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • FOR HAND WASHING TO HELP REDUCE BACTERIA ON THE SKIN.
    • RECOMMENDED FOR REPEATED USE.
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH 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

    KEEP EXPOSED CARTRIDGE OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT POISON CONTROL RIGHT AWAY.

  • DIRECTIONS

    • Wet Hands. - Pump a small amount of foam into palm of hand.
    • Rub thoroughly over all surfaces of both hands for 15 seconds.
    • Rinse with potable water.
  • INACTIVE INGREDIENTS

    Glycerine, PEG/PPG-18/18 Dimethicone, Water

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Black OPS AB-Dec 21

  • INGREDIENTS AND APPEARANCE
    BLACK OPS AB ANTIBACTERIAL FOAMING 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79016-103
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79016-103-121000 mL in 1 POUCH; Type 0: Not a Combination Product12/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/15/2021
    Labeler - Archer Manufacturing, Inc. (144669251)
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