Label: MEDICHOICE PVP SCRUB- povidone-iodine solution

  • NDC Code(s): 39892-0850-1, 39892-0850-2
  • Packager: Owens & Minor Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 20, 2024

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  • Drug Facts

  • Active ingredient

    Povidone-Iodine, USP 7.5% (equivalent to 1% titratable iodine)

    Purpose

    Antiseptic

  • Uses

    • Healthcare antiseptic for preparation of the skin prior to surgery.
    • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
  • Warnings

    For external use only.

    Do not use

    • in the eyes 
    • on individuals who are allergic or sensitive to iodine
    • over large areas of the body 
    • as first aid antiseptic longer than 1 week unless directed by doctor.

    Stop use and consult a doctor if

    • you have deep or puncture wounds
    • animal bites
    • serious burns 
    • the condition persists or gets worse
    • irritation and redness develop.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the affected area
    • for preparation of the skin prior to surgery, apply product to the operative site
    • for use as a first aid antiseptic, apply a small amount of product to the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.
  • Other information

    Store at room temperature 59º-86ºF (15º-30ºC)

  • Inactive ingredients

    citric acid monohydrate, sodium phosphate dibasic dihydrate, water

  • Pacakge Labeling:

    Label5

  • Pacakge Labeling:

    Label6

  • INGREDIENTS AND APPEARANCE
    MEDICHOICE PVP SCRUB 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39892-0850-1118 mL in 1 PACKAGE; Type 0: Not a Combination Product01/25/2024
    2NDC:39892-0850-248 in 1 CASE01/25/2024
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/25/2024
    Labeler - Owens & Minor Distribution, Inc. (847412269)
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