Label: MED NAP- 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 November 10, 2016

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  • Drug FactsActive Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    First Aid Antiseptic

  • Caution:

    Keep out of reach of children.

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

  • Use:

    Antiseptic Cleansing of face, hands and body.

  • Warnings


    For External Use Only.

    Do not use in or around the eyes.

    Do not apply over large area of the body.

  • Stop use

    if irritation, redness or other symptoms  develop.

    Consult a doctor if the condition persists or gets worse.

  • Directions

    Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after a single use.

  • Inactive Ingredients

    Water, Kathon CG

  • MED NAP BENZALKONIUM CHLORIDE TOWELETTE

    MED NAP

    Record No. 3303

    NDC # 59647-245-01

    BZK
    ANTISEPTIC
    TOWELETTE

    LatexFree

    1 Pouch

    Made by:
    MED-NAP LLC,
    Brooksville, FL 34601

    www.mednap.us

    Recorder No. 3303

    Made in the USA

    * See box for full Drug Facts information

    Lot: 16325 E F G    EXP: 10/2018

    Made In USA  1 REV 3

    MedNap BZK1

    MedNap BZK2

  • INGREDIENTS AND APPEARANCE
    MED NAP  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59647-245
    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:59647-245-01100 in 1 BOX09/09/2013
    1NDC:59647-245-001.7 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:59647-245-021000 in 1 BOX09/09/2013
    2NDC:59647-245-001.7 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 finalpart333E09/09/2013
    Labeler - Med-Nap LLC (079086400)
    Registrant - Med-Nap LLC (079086400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Nap LLC079086400manufacture(59647-245)
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