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: 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 December 1, 2020

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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 skin infection
    • for handwashing to reduce bacteria on the skin
    • significantly reduces the number of microorganisms on the hands 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 hands and forearms
      • without adding more water, scrub thoroughly for 2 1/2 to 3 minutes
      • use a sponge if desired. Clean thoroughly under fingernails.
      • add a little water and develop copious suds. Rinse thoroughly under 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, covering all 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-4 sulfate, nonoxynol-9, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    Avrio Health 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 Product07/01/1996
    3NDC:67618-151-171 in 1 CARTON07/01/1996
    3473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:67618-151-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/1996
    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 not finalpart333A07/01/1996
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thatcher Company041307356MANUFACTURE(67618-151)
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