Label: MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC- benzalkonium chloride liquid

  • 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 July 9, 2021

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

  • Drug Facts Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Caution:

    Keep out of reach of children.

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

  • Use:

    •First aid antisepticto help prevent skin infection in •Minor Cuts •Scrapes •Burns

    •Antiseptic Cleansing •Perineal and maternity care.

  • Warnings



    For External Use Only.

    Do not use •As an antiseptic for more than 1 week •in or around the eyes •Over large areas of the body.

  • Stop use

    if irritation and redness develop •if condition persists more than 72 hours, consult a physician.

    .

  • Directions

    •Tear at notch •Remove towelette •Use only once

    As a first aid antiseptic •Clean affected area •Apply 1 to 3 times daily •May be covered with a sterile bandage •If bandaged, let dry first

  • Other Information

    •Store at room temperature •Avoid excessive heat

  • Inactive Ingredients

    Water, methylchloroisothiazolinone, methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    Box Image

    Box Image

  • INGREDIENTS AND APPEARANCE
    MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1.7 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0245-001.7 mL in 1 PACKET; Type 0: Not a Combination Product07/09/2021
    2NDC:0924-0245-021000 in 1 BOX07/09/2021
    2NDC:0924-0245-001.7 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-0245-01100 in 1 BOX07/09/2021
    3NDC:0924-0245-001.7 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/09/2021
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0245) , repack(0924-0245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0245) , repack(0924-0245)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation117825595manufacture(0924-0245)