Label: AMSURE THREE POVIDONE-IODINE SWABSTICKS- povidone-iodine swab

  • NDC Code(s): 67752-2003-3
  • Packager: Amsino International, Inc.
  • 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 February 2, 2012

If you are a consumer or patient please visit this version.

  • Active Ingredient Section

    Active ingredient
                                                                                          
    Povidone Iodine USP, 10% W/V (equivaient to 1% tiratable iodine) Close
  • Purpose Section

    Purpose Antiseptic Close
  • Stop Use Section

    Stop use and ask a doctor if skin irritation, redness, swelling, or pain occurs.

    Close
  • Warnings Section

    Warnings • Do not use if allergic to iodine • For external use only • Do not use in eyes • Avoid
    pooling beneath patient •  In case of accidental ingestion, seek professional
    assistance or consult a poison control center immediately.

    Keep Out of Reach of Children Section

    Keep out of reach of children.

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  • Indications and Uses Section

    Uses antiseptic skin preparation

    Directions Section

    Directions apply locally as needed

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  • Inactive Ingredients Section

    Inactive ingredients
    Citric Acid, Glycerol, Nonoxynol-10, Sodium hydroxide, water Close
  • Questions Section

    Questions?    Call 1-800-632-6746 Close
  • Other Information Section

    Other information

    For Hospital or Professional Use Only.

    Store at room temperature: 15oC - 30oC

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  • Package Label


    AMSINO  AMSure Three Povidone-Iodine Swabsticks  NDC 67752-2003-3  REF  PIS2003

    Three 4-inch saturated swabsticks  Sterile, unless opened or damaged  DO NOT RE-USE LATEX-FREE

    Distributed by: Amsion International, inc. 855 Towne Center Dr., Pomona, CA 91757, USA  AMSure is a registered trademark of Amsino International, Inc.  Made in China  L5332  Rev. D

    Tear open   LOT       EXP.

    AMSure Label






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  • INGREDIENTS AND APPEARANCE
    AMSURE   THREE POVIDONE-IODINE SWABSTICKS
    povidone-iodine swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67752-2003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M) Povidone-Iodine 0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67752-2003-3 6 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/06/2012
    Labeler - Amsino International, Inc. (825673239)
    Registrant - Amsino International, Inc. (825673239)
    Close