Label: POVIDONE-IODINE PAD - povidone-iodine swab

  • NDC Code(s): 42339-002-01, 42339-002-02
  • Packager: Shandong Haiyan Medical Manufacture Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 9, 2012

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  • Active Ingredient

    Povidone Iodine 10% w/w (equivalent to iodine 1%)

    Purpose

    Antiseptic
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  • Use

    Antiseptic for preparation of the skin. Close
  • Warnings

    For external use only.

    Discontinue use if irritation and redness develop.

    Keep out of reach of Children.
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  • Directions


    Apply locally as needed.
    Other Information
    Store at room temperature: 59°- 86°F(15 - 30℃) Close
  • Inactive ingredients

    Purified Water Close
  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PAD 
    povidone-iodine swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:42339-002
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 9.43 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42339-002-01 10 in 1 CONTAINER
    1 100 in 1 BOX
    1 0.6 g in 1 POUCH
    2 NDC:42339-002-02 100 in 1 CONTAINER
    2 100 in 1 BOX
    2 0.6 g in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 02/18/2012
    Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)
    Establishment
    Name Address ID/FEI Business Operations
    Shandong Haiyan Medical Manufacture Co., Ltd. 421283439 manufacture
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