Label: ANTISEPTIC BANDAGES- benzalkonium chloride dressing

  • 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 22, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.1%

  • Purpose

    Antiseptic

  • Uses

    First aid to help reduce the risk of infection in minor cuts, scrapes, and burns

  • Warnings

    • For external use only.
  • Stop use and consult a doctor

    if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

  • Keep out of reach of children.

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

  • Directions

    Clean and dry the affected area. Apply a sterile bandage on the area 1 to 3 times daily.

  • Inactive Ingredients: 

    None

  • Other Information: 

    Not intended for use on delicate or sensitive skin.


  • PRINCIPAL DISPLAY PANEL

    PharmaBand
    Antiseptic Bandages
    20
    Antiseptic
    Bandages

    PRINCIPAL DISPLAY PANEL PharmaBand Antiseptic Bandages 20 Antiseptic Bandages

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC BANDAGES 
    benzalkonium chloride dressing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69225-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.042 mg
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    Does not containNATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) 0 
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69225-1000-220 in 1 BOX; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    2NDC:69225-1000-330 in 1 BOX; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    3NDC:69225-1000-440 in 1 BOX; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E01/09/2014
    Labeler - Pharmaband (850528574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaband850528574ANALYSIS(69225-1000) , LABEL(69225-1000) , MANUFACTURE(69225-1000) , PACK(69225-1000)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!