Label: ANTISEPTIC BANDAGES- benzalkonium chloride dressing

  • NDC Code(s): 28691-0010-5, 28691-0010-6, 28691-0010-7
  • Packager: Pharmaplast SAE
  • Category: HUMAN OTC DRUG LABEL

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 November 7, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredients

    Benzalkonium Chloride 0.1%

  • Purpose

    Topical antimicrobial adhesive bandage

  • 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

  • SPL UNCLASSIFIED SECTION

    CURE-AID®

    INTENDED USE:
    Antimicrobial Adhesive Bandages are to be applied to the skin for topical application. The bandages help provide an antibacterial barrier for minor cuts and scrapes.

    DIRECTIONS:
    Apply bandages to clean, dry skin. Change daily or when pad becomes wet. Sterile unless wrapper is damaged or open.

    WARNINGS:
    FOR MEDICAL EMERGENCIES SEEK PROFESSIONAL HELP

    GERM FIGHTING PROTECTION
    • Help prevent infection • Safe for all minor cuts and scrapes • Unique, long lasting adhesive • Medicated non-stick pad

    • Each strip has been sealed and sterilized for your protection.
    • Be sure skin is clean and dry before applying. Change bandage as needed.
    • Sterility guaranteed unless individual envelope has been opened or damaged.

    Pharmaplast

    Amria – Alexandria
    Egypt
    www.Pharmaplast-online.com

  • Packaging

    label

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC BANDAGES 
    benzalkonium chloride dressing
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28691-0010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    Does not containNATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) 0 mg  in 100 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28691-0010-520 in 1 BOX10/07/2016
    10.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    2NDC:28691-0010-630 in 1 BOX10/07/2016
    20.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    3NDC:28691-0010-740 in 1 BOX10/07/2016
    30.033 mg in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/07/2016
    Labeler - Pharmaplast SAE (644773319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaplast SAE644773319analysis(28691-0010) , label(28691-0010) , manufacture(28691-0010) , pack(28691-0010)
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

More Info on this Drug

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