Label: BETADINE SOLUTION SWABSTICKS- povidone-iodine swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 15, 2011

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  • Drug Facts

    Active Ingredient Purpose

    Povidone-iodine Solution USP, 10% (equal to 1% available iodine)

  • Purpose

    Antiseptic

  • Uses

    • for preparation of the skin prior to surgery
    • helps reduce bacteria that can potentially cause skin infection
  • Warnings

    For external use only

    Do not use this product

    • in the eyes
    • if you are allergic to iodine or other product ingredients

    When using this product

    • prolonged exposure may cause irritation or, rarely, severe skin reactions

    Stop using this product

    • in rare instances of local irritation or sensitivity
    • if irritation and redness develop and continue for more than 72 hours

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • tear at slit; pull top of packette across, exposing end of swabstick
    • remove Betadine Solution Swabstick and apply as needed
    • use one time only
  • Other information

    • store between 20°-25°C (68°-77°F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    citric acid, disodium phosphate, nonoxynol-9, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Dist. by: Purdue Products L.P. Stamford, CT 06901-3431

    L01119B 301880-0A

  • PRINCIPAL DISPLAY PANEL

    Betadine Solution Swabsticks
    NDC 67618-153-01

    Betadine Solution Swabsticks NDC 67618-153-01
  • PRINCIPAL DISPLAY PANEL

    Betadine Solution Swabsticks
    NDC 67618-153-03

    Betadine Solution Swabsticks NDC 67618-153-03
  • INGREDIENTS AND APPEARANCE
    BETADINE  SOLUTION SWABSTICKS
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE.01 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-153-011 in 1 PACKET
    2NDC:67618-153-033 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/1972
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Products LP (141916531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Inc.107255002MANUFACTURE