Label: MED NAP BENZALKONIUM CHLORIDE ANTISEPTIC- benzalkonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 9, 2021

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  • 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)
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