Label: BETADINE SKIN CLEANSER- povidone-iodine solution

  • 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 January 27, 2016

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredient

    Povidone-iodine, 7.5% – equal to 0.75% available iodine

  • PURPOSE

    Purpose

    First aid antiseptic

  • INDICATIONS & USAGE

    Uses

    • disinfectant hand wash and skin cleanser
    • significantly reduces bacteria on the skin
  • INDICATIONS & USAGE

    Warnings
    For external use only

    Do not use this product

    • in the eyes
    • over large areas of the body
    • If you are allergic to povidone-iodine or any other ingredients in this preparation
    • Longer than 1 week unless directed by a doctor
  • DO NOT USE

    Ask a doctor before use if you have

    • deep or puncture wounds
    • serious burns
    • animal bites
  • STOP USE

    Stop using this product and ask a doctor if

    • redness, irritation, swelling, or pain continues or increases
    • infection occurs
  • 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.

  • WHEN USING

    Directions

    • wet skin and apply a sufficient amount for lather to cover all surfaces
    • wash vigorously for at least 15 seconds
    • rinse and dry thoroughly
  • HOW SUPPLIED

    Other information

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

    Inactive ingredients

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

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

    301011-0F

    ©2015, Purdue Products L.P.


  • DOSAGE FORMS & STRENGTHS

  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • PRINCIPAL DISPLAY PANEL

    Betadine Skin Cleanser
    NDC: 67618-149-04

    Betadine Skin Cleanser
  • INGREDIENTS AND APPEARANCE
    BETADINE SKIN CLEANSER 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 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:67618-149-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/198007/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/198007/01/2021
    Labeler - Purdue Products LP (141916531)
    Registrant - Purdue Pharma LP (932323652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thatcher Company041307356MANUFACTURE(67618-149)