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

  • 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.

View All Sections
  • Active Ingredient Section

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

    Purpose Antiseptic
  • Stop Use Section

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

  • 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.

  • Indications and Uses Section

    Uses antiseptic skin preparation

    Directions Section

    Directions apply locally as needed

  • Inactive Ingredients Section

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

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

    Other information

    For Hospital or Professional Use Only.

    Store at room temperature: 15oC - 30oC

  • 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






  • INGREDIENTS AND APPEARANCE
    AMSURE   THREE POVIDONE-IODINE SWABSTICKS
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67752-2003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M) Povidone-Iodine0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67752-2003-36 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/06/2012
    Labeler - Amsino International, Inc. (825673239)
    Registrant - Amsino International, Inc. (825673239)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!