Label: BETADINE SOLUTION- povidone-iodine solution

  • NDC Code(s): 67618-150-01, 67618-150-04, 67618-150-05, 67618-150-09, view more
    67618-150-17, 67618-150-32
  • 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 November 16, 2020

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

  • Drug Facts

    Active ingredient

    Povidone-iodine, 10% (1% available iodine)

  • Purpose

    Antiseptic

  • Uses

    Patient pre-operative skin preparation

    • for preparation of the skin prior to surgery
    • helps reduce bacteria that potentially can cause skin infection
  • Warnings

    For external use only

  • Do not use

    • in the eyes
    • if you are allergic to povidone-iodine or any other ingredients in this preparation
  • When using this product

    • single use will reduce the risk of infection from extrinsic contamination
    • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
    • in pre-operative prepping, avoid “pooling” beneath the patient
  • Stop use and ask a doctor if

    • irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • single use may prevent extrinsic contamination
    • clean the operative site prior to surgery
    • apply product and allow to dry
    • may be covered with a bandage
  • Other information

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

    pareth 25-9, purified water, sodium hydroxide

  • SPL UNCLASSIFIED SECTION

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

    ©2018, Avrio Health L.P.

  • PRINCIPAL DISPLAY PANEL

    Betadine Solution 8 oz
    NDC: 67618-150-09

    Betadine Solution 8 oz
  • INGREDIENTS AND APPEARANCE
    BETADINE  SOLUTION
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-150
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    C12-15 PARETH-9 (UNII: H3ZIY6WP1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-150-09237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    2NDC:67618-150-0514.8 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    3NDC:67618-150-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    4NDC:67618-150-17473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    5NDC:67618-150-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    6NDC:67618-150-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/1980
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/1980
    Labeler - Avrio Health L.P. (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thatcher Company041307356MANUFACTURE(67618-150)