Label: MED NAP OBSTETRICAL- 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 October 28, 2016

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  • Drug Facts Active Ingredient

    Benzalkonium Chloride, 0.13% v/v

  • Purpose

    Antiseptic

  • Keep out of reach of children

    Keep out of reach of children.

    If swallowed, get medical help or contact a poison Control Center right away.

  • Uses

    • First aid antiseptic to help prevent skin infection in:
    • Minor Cuts
    • Scrapes
    • Burns
    • Antiseptic Cleaning
    • Perineal and maternity care
  • Warnings

    For External Use Only.

  • Do not use

    • As an antiseptic for more than 1 week
    • In the eyes
    • Over large areas of the body
  • Ask a doctor before use if you have

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • 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, Alcohol 5% v/v, Chlorothymol, Kathon CG

  • MED NAP OBSTETRICAL TOWELETTE

    NDC # 59647-244-01

    MED NAP

    OBSTETRICAL TOWELETTE

    100 Packets
    Latex Free

    Made by:
    MED-NAP LLC,
    Brooksville, FL 34601
    www.mednap.us

    Reorder No. 3302

    Made in USA

    MedNap OB

  • INGREDIENTS AND APPEARANCE
    MED NAP OBSTETRICAL  
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59647-244
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    CHLOROTHYMOL (UNII: LJ25TI0CVT)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59647-244-01100 in 1 BOX09/09/2013
    1NDC:59647-244-001.7 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(59647-244)
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