Label: BETADINE CREAM- povidone-iodine cream

  • 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, 5% (0.5% available iodine)

  • PURPOSE

    Purpose
    First aid antiseptic

  • INDICATIONS & USAGE

    Uses
    First aid to help prevent infection in minor

    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings For external use only

    Do not use

    • in the eyes
    • over large areas of the body
    • if you are allergic to povidone-iodine or any other ingredients in this preparation

    Ask a doctor before use if you have

    • deep or puncture wounds
    • serious burns
    • animal bites

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • you need to use this product for more than 1 week

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

  • WHEN USING

    Directions

    • clean the affected area
    • apply a small amount of product (equal to the surface area of a fingertip) to the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • HOW SUPPLIED

    Other information

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

    Inactive ingredients
    cetostearyl alcohol,glycerin, mineral oil, PEG-50 stearate, polysorbate 60, potassium iodate, sodium hydroxide, sorbitan monostearate, water, white petrolatum

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

    305099-0B

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL

    Betadine Cream
    NDC: 67618-180-12

    Betadine-Cream-Carton
  • INGREDIENTS AND APPEARANCE
    BETADINE CREAM 
    povidone-iodine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.05 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    glycerin (UNII: PDC6A3C0OX)  
    mineral oil (UNII: T5L8T28FGP)  
    PEG-50 stearate (UNII: 776CJK5X56)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    potassium iodate (UNII: I139E44NHL)  
    sodium hydroxide (UNII: 55X04QC32I)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    water (UNII: 059QF0KO0R)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-180-121 in 1 CARTON06/01/1980
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    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
    Mundipharma Pharmaceuticals Limited365982441MANUFACTURE(67618-180)