Label: MED NAP OBSTETRICAL - benzalkonium chloride liquid

  • NDC Code(s): 59647-244-00, 59647-244-01
  • Packager: Med-Nap LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/13

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

  • Drug Facts Active Ingredient

    Benzalkonium Chloride, 0.13% v/v

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  • Purpose

    Antiseptic

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  • 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.

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  • Uses

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

    For External Use Only.

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  • Do not use

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

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
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  • Stop use

    • If irritation and redness develop
    • If condition persists more than 72 hours, consult a physician
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  • Directions As a first aid antiseptic

    • Tear at notch
    • Remove towelette
    • Use only once
    • Clean affected area
    • Apply 1 to 3 times daily
    • May be covered with a sterile bandage
    • If bandaged, let dry first
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  • Other information

    • Store at room temperature
    • Avoid excessive heat
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  • Inactive Ingredients

    Water, Alcohol 5% v/v, Chlorothymol

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  • Product Label

    NDC # 59647-244-01

    MED NAP

    OBSTETRICAL TOWELETTE

    100 Packets

    made by: MED-NAP LLC,

    Brooksville, FL 34601

    Reorder No. 3302

    Made in USA

    Lot No.

    MedNap OB Label

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  • INGREDIENTS AND APPEARANCE
    MED NAP OBSTETRICAL  
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59647-244
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1.3 mg  in 1.7 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ALCOHOL  
    CHLOROTHYMOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59647-244-01 100 in 1 BOX
    1 NDC:59647-244-00 1.7 mL in 1 PACKET
    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(59647-244)
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