Label: BETADINE- 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 23, 2014

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  • Active ingredient

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

  • Purpose

    Antiseptic

  • Uses

    • for preparation of skin prior to surgery
    • helps reduce bacteria that potentially can 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

    • if irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
    • in rare instances of local irritation or sensitivity
  • Keep out of reach of children.

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

  • Directions

    • tear slit; pull top of packette up and away, exposing pad
    • use pad to swab area thoroughly
    • repeat using the other side if necessary
    • use one time only. Each packette contains 1 Swab Aid Antiseptic pad.
  • Other information

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

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

  • SPL UNCLASSIFIED SECTION

    ©2013, Purdue Products L.P.

    Dist by: Purdue Products L.P.
    Stamford, CT 06901-3431
    300983-0D

  • PRINCIPAL DISPLAY PANEL

    Betadine Solution Swab Aid Antiseptic Pads - Carton
    NDC 67618-152-01

    Betadine Carton
  • INGREDIENTS AND APPEARANCE
    BETADINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-152-01100 in 1 CARTON
    10.01 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/1992
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Inc107255002MANUFACTURE(67618-152)