Label: POVIDONE-IODINE PAD- povidone-iodine swab

  • Category: HUMAN OTC DRUG LABEL

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

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredient

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

    Purpose

    Antiseptic
  • Use

    Antiseptic for preparation of the skin.
  • Warnings

    For external use only.

    Discontinue use if irritation and redness develop.

    Keep out of reach of Children.
  • Directions


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

    Purified Water
  • PRINCIPAL DISPLAY PANEL

    haiyan002
  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42339-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE9.43 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42339-002-0110 in 1 CONTAINER
    1100 in 1 BOX
    10.6 g in 1 POUCH
    2NDC:42339-002-02100 in 1 CONTAINER
    2100 in 1 BOX
    20.6 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/18/2012
    Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Haiyan Medical Manufacture Co., Ltd. 421283439manufacture
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

More Info on this Drug

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