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 22, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • 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 POUCH09/15/1972
    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 DrugM00309/15/1972
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!