Label: ANTISEPTIC TOWELETTE- 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 February 9, 2016

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  • Active Ingredients

    Benzalkonium Chloride 0.133%

  • Purpose

    First Aid Antiseptic

  • Keep out of reach of children.

    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 without soap and water. Air dries in seconds.

  • WARNINGS:

    For external use only. Do not use in or around the eyes.

  • Directions

    Tear open packet, unfold and use as a washcloth.

  • Stop Use

    if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or gets worse.

  • Inactive Ingredients

    Kathon CG, Water

  • Antiseptic Towelette Label WET NAP bulk product Label

    MAX

    PACKAGING


    NDC 59647-750-01

    Antiseptic Towelette

    Contains Benzalkoniun Chloride

    For External use Only

    1 Towelette

    MAX PACKAGING

    Attalla, AL

    (256) 538-543www.maxpackaging.com

    Made in USA

    EXP: 03/2018

    LOT MN06916 ABC

    MedNap Towelette

    WET NAP

    60,000

    MAX

    ANTISEPTIC

    LOT #15048 MAX-BZK

    MedNap Bulk Towelette

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC  TOWELETTE
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59647-750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.1 mg  in 1.4 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:59647-750-0060000 in 1 CONTAINER02/15/2016
    1NDC:59647-750-011.4 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 finalpart333A02/15/2016
    Labeler - Med-Nap LLC (079086400)
    Registrant - Med-Nap LLC (079086400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Med-Nap LLC079086400manufacture(59647-750)
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