OBSTETRICAL ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [WUXI MEDICAL INSTRUMENT FACTORY]

OBSTETRICAL ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [WUXI MEDICAL INSTRUMENT FACTORY]
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NDC 42947-630-03
Set ID 4ee8955d-9e82-46fd-88c5-b45196145285
Category HUMAN OTC DRUG LABEL
Packager Wuxi Medical Instrument Factory
Generic Name
Product Class
Product Number
Application Number PART333
  • PRINCIPAL DISPLAY PANEL

    Item# 83791-510-003      NDC#42947-630-03      Qty.1ea

    Obstetrical Antiseptic Towelette

    Contains: Benzalkonium Chloride 0.13%

    For Single Use Only

    Caution: Keep out of reach of children

    Manufactured by: Wuxi Medical Instrument Factory

    No.86 East street, Zhangjing, Wuxi, Jiangsu 214194 China

    Made in China

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride, 0.13% w/w

  • PURPOSE

    Purpose

    First Aid Antiseptic

  • WHEN USING

    Use

    First aid antiseptic to help prevent infection in minor cuts, scrapes, and burns

  • WARNINGS

    Warnings
    For external use only. Do not use

    In the eyes or apply over large areas of the body
    longer than 1 week unless directed by a doctor.
    In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • STOP USE

    Stop use and consult a doctor

    if the condition persists or gets worse.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right way.

  • INDICATIONS & USAGE

    Directions

    * Clean the affected area

    * Apply a small amount of this product on the area 1 to 3 times daily

    * May be covered with a sterile bandage when dry

  • INACTIVE INGREDIENT

    Inactive ingredients

    purified water, sodium bicarbonate

  • PRINCIPAL DISPLAY PANEL

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    OBSTETRICAL ANTISEPTIC 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42947-630
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42947-630-031.4 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33301/01/2009
    Labeler - Wuxi Medical Instrument Factory (421292863)
    Registrant - Wuxi Medical Instrument Factory (421292863)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wuxi Medical Instrument Factory421292863manufacture

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