Label: OMNICIDE ANTIMICROBIAL- benzalkonium chloride gel

  • 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 25, 2023

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  • Active Ingredient

    Benzalkonium Chloride   0.13% w/w

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help treat, protect and prevent skin infection associated with

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • When using this product

    • Do not use in or near the eyes
    • Do not use if you have a history of allergy to any of the ingredients
  • Stop and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days, or clear up and occur again within a few days.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first)
    • children under 2 years: ask a doctor
  • Other information

    Avoid excessive heat.

  • Inactive Ingredients

    USP Petrolatum, Water, Polihexanide (PHBM)

  • Questions?

    1-360-448-7881

    or www.steriwebrx.com

  • PRINCIPAL DISPLAY PANEL

    omnicidef

  • INGREDIENTS AND APPEARANCE
    OMNICIDE ANTIMICROBIAL 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69085-466
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69085-466-0245 g in 1 TUBE; Type 0: Not a Combination Product07/02/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2014
    Labeler - SteriWeb Medical, LLC (079409860)
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