Label: POVIDONE IODINE PREP PAD- povidone-iodine swab

  • NDC Code(s): 34645-4008-3
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 22, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient

    Povidone-Iodine USP, 10% w/v (equivalent to 1% titratable iodine)

  • PURPOSE

    Purpose

    First Aid Antiseptic

  • INDICATIONS & USAGE

    Use

    First aid to help prevent infection in minor cuts, scraps, and burns

  • WARNINGS

    Warnings

    For external use only



  • DO NOT USE

    Do not

    use in the eyes

    apply over large areas of the body

    use on individuals who are allergic or sensitive to iodine

  • STOP USE

    Stop use and consult a doctor

    if the condition persists or gets worse

    for use longer than 1 week

  • ASK DOCTOR

    Ask a doctor

    in case of deep or puncture wounds, animal bites, serious burns

  • 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

  • Directions

    Clean the affected area

    Apply product on the area 1-3 time daily and discard

    May be covered with a sterile bandage when dry

  • INACTIVE INGREDIENT

    Inactive Ingredients

    citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide


  • PRINCIPAL DISPLAY PANEL

    Image of Pouch label

    Pouch Label
  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-4008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-4008-30.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/01/2010
    Labeler - Jianerkang Medical Co., Ltd (530968767)
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!