Label: BAC-D ANTIBACTERIAL WOUND AND SKIN CARE- benzalkonium chloride spray

  • 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 November 10, 2015

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  • Active ingredient 

    Benzalkonium chloride 0.13 %

  • Purpose

    First aid Product

  • Keep out of reach of children.

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

  • Uses

    First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes, burns and post-surgical incision sites.

  • Warnings

    For external use only. 

    Do not use

    • in the eyes or apply over large areas of the body  longer than 1 week unless directed by a doctor
  • Directions for use

    • Clean the affected area
    • Spray a small amount of this product on the area 1 to 3 times a day.
    • May be covered with a sterile  bandage
    • If bandaged let dry first
  • Inactive ingredients 

    Ionized water, Carbamide

  • SPL UNCLASSIFIED SECTION

    Made in the U.S.A 

    Manufactured for 

    RDM Products Inc.

    910-491-7371

    PO Box 35003

    Fayetteville, NC 28303

    www.BAC-D.com

  • Packaging

    AnimalSpray

  • INGREDIENTS AND APPEARANCE
    BAC-D ANTIBACTERIAL WOUND AND SKIN CARE 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69082-500
    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
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69082-500-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/12/2014
    Labeler - RDM Products, Inc (034340230)
    Establishment
    NameAddressID/FEIBusiness Operations
    RDM Products, Inc034340230manufacture(69082-500)
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