Label: BETADINE SOLUTION SWABSTICKS- povidone-iodine solution

  • NDC Code(s): 67618-153-01, 67618-153-03
  • Packager: Avrio Health L.P.
  • 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 March 22, 2022

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  • 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

    purified water, sodium hydroxide

    Dist. by:
    Avrio Health L.P.
    Stamford, CT 06901-3431

  • PRINCIPAL DISPLAY PANEL

    Betadine Swabsticks — 1 Swab
    NDC: 67618-153-01

    NDC 67618-153-01

    Betadine Swabsticks — 3 Swabs
    67618-153-03

    NDC 67618-153-03
  • INGREDIENTS AND APPEARANCE
    BETADINE   SOLUTION SWABSTICKS
    povidone-iodine solution
    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) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-153-011 in 1 POUCH09/15/1972
    11.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:67618-153-033 in 1 POUCH09/15/1972
    21.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/1972
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc. 800777117MANUFACTURE(67618-153)