Label: BETADINE SOLUTION SWABSTICKS- povidone-iodine solution

  • NDC Code(s): 67618-153-01, 67618-153-03
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2024

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  • Active ingredient Purpose

    Povidone-iodine Solution USP, 10% (equal to1% 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, severeskin reactions
  • Stop using this product

    • in rare instances of local irritation or sensitivity
    • if irritation and redness develop and continue for morethan 72 hours
  • Keep out of reach ofchildren.

    Ifswallowed, get medical help or contact a Poison Control Center rightaway

  • Directions

    • tear at slit; pull top of packette across, exposing endof 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

    BetadineSwabsticks — 1 Swab
    NDC: 67618-153-01

    NDC 67618-153-01

    BetadineSwabsticks — 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 POUCH09/15/197207/31/2021
    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 DrugM00309/15/1972
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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