Label: POVIDONE-IODINE PREP PAD- 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 January 31, 2012

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

View All Sections
  • Active Ingredient

    POVIDONE-IODINE 10% W/v (equivalent to iodine 1%)

    Purpose

    Antiseptic

  • Warnings

    For External use only.
    Discontinue use if irritation and redness develop

    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

    Apple locally as needed.

  • Other information

    Store at room temperature:59o-86oF(15--30℃)

    Use

    Antiseptic for preparation of the skin
  • Inactive Ingredients

    Water，Citric acid,  Disodium phosphate, Nonoxynol-9, Sodium Hydroxide,Purified Water
  • PRINCIPAL DISPLAY PANEL

    Enter section text herelabel of strip1

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35617-392
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 89.96 mL
    Citric acid (UNII: 2968PHW8QP) 0.01 mL
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) 0.01 mL
    NONOXYNOL-9 (UNII: 48Q180SH9T) 0.01 mL
    Sodium Hydroxide (UNII: 55X04QC32I) 0.01 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35617-392-81100 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/17/2010
    Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519manufacture
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!