Label: BETADINE SURGICAL SCRUB- povidone-iodine solution

  • NDC Code(s): 67618-151-01, 67618-151-04, 67618-151-16, 67618-151-17, view more
    67618-151-32
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 22, 2023

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  • ACTIVE INGREDIENT

    Drug Facts


    Active ingredient

    Povidone-iodine, 7.5%(0.75% available iodine)

  • PURPOSE

    Purpose

    Antiseptic

    Uses

    • helps to reduce bacteria that potentially can cause skininfection
    • for handwashing to reduce bacteria on the skin
    • significantly reduces the number of microorganisms on thehands and forearms prior to surgery or patient care
  • WARNINGS

    Warnings

    For external use only

    Do not use this product

    • in the eyes

    When using this product

    • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions

    Stop use and ask a doctor

    • if irritation and redness develop
    • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    1. Surgical hand scrub:
      • wet hands with water
      • spread about 5 cc (1 teaspoonful) of Scrub over both handsand forearms
      • without adding more water, scrub thoroughly for 2 1/2 to3 minutes
      • use a sponge if desired. Clean thoroughly under fingernails.
      • add a little water and develop copious suds. Rinse thoroughlyunder running water.
      • repeat the entire procedure using another 5 cc of Scrub
    2. Antiseptic hand wash:
      • wet hands with water and pour about 5 cc of Scrub on hands
      • rub hands vigorously together for at least 15 seconds, coveringall surfaces
      • rinse and dry with a disposable towel
  • STORAGE AND HANDLING

    Other information

    • store at 25°C (77°F); excursions permitted between 15°-30°C(59°-86°F)
    • store in original container
  • INACTIVE INGREDIENT

    Inactive ingredients

    ammonium nonoxynol-4sulfate, nonoxynol-9, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

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

    304954-0A

  • PRINCIPAL DISPLAY PANEL

    Betadine Surgical Scrub
    NDC 67618-151-17

    NDC 67618-150-17
  • INGREDIENTS AND APPEARANCE
    BETADINE  SURGICAL SCRUB
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-151
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.075 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-151-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1996
    2NDC:67618-151-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/199601/31/2025
    3NDC:67618-151-171 in 1 CARTON07/01/199601/31/2025
    3473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:67618-151-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/199611/30/2024
    5NDC:67618-151-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1996
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00307/01/1996
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
    Registrant - Atlantis Consumer Healthcare, Inc. (118983925)
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