Label: MED NAP - benzalkonium chloride liquid

  • NDC Code(s): 59647-245-00, 59647-245-01, 59647-245-02
  • Packager: Med-Nap LLC
  • 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

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

  • Drug Facts Active Ingredient

    Benzalkonium Chloride 0.13%

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  • Purpose

    First Aid Antiseptic

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  • Caution:

    Keep out of reach of children.

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

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  • Use:

    Antiseptic Cleansing of face, hands and body.

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  • Warnings


    For External Use Only.

    Do not use in or around the eyes.

    Do not apply over large area of the body.

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  • Stop use

    if irritation, redness or other symptoms  develop.

    Consult a doctor if the condition persists or gets worse.

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  • Directions

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

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  • Inactive Ingredients

    Water, Kathon CG

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  • 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

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  • INGREDIENTS AND APPEARANCE
    MED NAP  
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59647-245
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg  in 1.7 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59647-245-01 100 in 1 BOX 09/09/2013
    1 NDC:59647-245-00 1.7 mL in 1 PACKET; Type 0: Not a Combination Product
    2 NDC:59647-245-02 1000 in 1 BOX 09/09/2013
    2 NDC:59647-245-00 1.7 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 09/09/2013
    Labeler - Med-Nap LLC (079086400)
    Registrant - Med-Nap LLC (079086400)
    Establishment
    Name Address ID/FEI Business Operations
    Med-Nap LLC 079086400 manufacture(59647-245)
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