Label: GOOD CARE POVIDONE IODINE PAD- povidone-iodine swab

  • NDC Code(s): 50685-007-01
  • Packager: Dalian Goodwood Medical Care Ltd.
  • 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 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
  • 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
    animal bites
    serious burns

  • 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.


  • STORAGE AND HANDLING

    Other information

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

  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified water

  • SPL UNCLASSIFIED SECTION

    Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

    Made in China www.dl-goodwood.com

  • PRINCIPAL DISPLAY PANEL

    Good Care

    Povidone Iodine pad
    10% povidone iodine

    For Disinfection Use

  • PRINCIPAL DISPLAY PANEL

    PI10

  • INGREDIENTS AND APPEARANCE
    GOOD CARE POVIDONE IODINE PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50685-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50685-007-010.4 mL in 1 POUCH; Type 0: Not a Combination Product03/23/201104/30/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/201104/30/2026
    Labeler - Dalian Goodwood Medical Care Ltd. (529575699)
    Registrant - Dalian Goodwood Medical Care Ltd. (529575699)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Goodwood Medical Care Ltd.529575699manufacture(50685-007)
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