SWAB (POVIDONE-IODINE) SWAB [MCKESSON MEDICAL-SURGICAL INC.]

SWAB (POVIDONE-IODINE) SWAB [MCKESSON MEDICAL-SURGICAL INC.]
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NDC 68599-8630-1, 68599-8630-2, 68599-8630-3, 68599-8630-4, 68599-8630-5, 68599-8630-6
Set ID 4777b5f4-1698-08da-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager McKesson Medical-Surgical Inc.
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Health-care antiseptic for preparation of the skin prior to surgery.

    First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns.

  • WARNINGS

    For external use only.

    Do not use or apply • in the eyes • on individuals who are allergic or sensitive to iodine • over large areas of the body • as a first aid antiseptic longer than 1 week unless directed by a doctor

    Discontinue use if irritation and redness develop

    Consult a doctor in case of • deep or puncture wounds • animal bites • serious burns

    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 away.

  • DOSAGE & ADMINISTRATION

    For preparation of the skin prior to surgery • clean the affected area • remove swab by stick • apply to the operative site prior to surgery

    For use as a first aid antiseptic • clean the affected area • apply a small amount of this product on the area 1 - 3 times daily • May be covered with a sterile bandage • If bandaged, let dry first

  • OTHER SAFETY INFORMATION

    Store at 59-86ºF (15-30ºC).

  • INACTIVE INGREDIENT

    Citric Acid, Sodium Hydroxide, Nonoxynol-10, Glycerin, Water.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SWAB 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-8630
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-8630-310 in 1 CASE01/17/2017
    1NDC:68599-8630-250 in 1 BOX
    1NDC:68599-8630-11 in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:68599-8630-610 in 1 CASE01/17/2017
    2NDC:68599-8630-525 in 1 BOX
    2NDC:68599-8630-43 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/17/2017
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Province Jianerkang Medical Dressing Co.,Ltd530968767manufacture(68599-8630)

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