BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]

BETADINE SOLUTION SWABSTICKS (POVIDONE-IODINE) SWAB [PURDUE PRODUCTS LP]
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NDC 67618-153-01, 67618-153-03
Set ID 0707b259-52a4-4ae6-b176-d093865906e7
Category HUMAN OTC DRUG LABEL
Packager Purdue Products LP
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333A
  • 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