Label: GOOD CARE POVIDONE IODINE- povidone-iodine swab

  • NDC Code(s): 50685-001-01, 50685-001-03
  • Packager: Dalian Goodwood Medical Care Ltd.
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated May 25, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Povidone Iodine USP, 10% w/v

    (equivalent to 1% titratable iodine)

  • PURPOSE

    Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • 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

    Warnings

    For external use only.

  • DO NOT USE

    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.
  • 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 away.

  • DOSAGE & ADMINISTRATION

    Directions

    For preparation of the skin prior to surgery clean the affected area, remove swab by the 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.

  • STORAGE AND HANDLING

    Other information

    Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

    3-91 Jiulicun Yongzheng Street Jinzhou District Dalian China 116100

    Tel: +86-411-87857288

    Made in China  www.dl-goodwood.com

  • PRINCIPAL DISPLAY PANEL

    Good Care
    Povidone Iodine, USP Swabsticks
    Antiseptic    Germicide

    • Topical pre-surgical and first aid antiseptic swabstick
    • For hospital and professional use only
  • PRINCIPAL DISPLAY PANEL

    PIS1

  • INGREDIENTS AND APPEARANCE
    GOOD CARE POVIDONE IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50685-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50685-001-012 mL in 1 POUCH; Type 0: Not a Combination Product10/01/201004/30/2026
    2NDC:50685-001-035.5 mL in 1 POUCH; Type 0: Not a Combination Product10/01/201004/30/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/201004/30/2026
    Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
    Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Goodwood Medical Care Ltd. 529575699manufacture(50685-001)