Label: PVP SCRUB SOLUTION- povidone iodine solution

  • NDC Code(s): 68599-3501-1, 68599-3501-2, 68599-3501-5, 68599-3501-6
  • Packager: McKesson Medical-Surgical Inc.
  • 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 May 21, 2020

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

  • PURPOSE

    Antiseptic

  • WARNINGS

    For external use only

    Do not • heat prior to application • use on individuals who are allergic or sensitive to iodine

  • KEEP OUT OF REACH OF CHILDREN

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

  • OTHER SAFETY INFORMATION

    Do not store above 77°F (25ºC) - Do not store below 68°F (20°C)

    Not made with natural rubber latex

  • INACTIVE INGREDIENT

    Disodium Phosphate, Glycerin, Hydroxy Ethyl Cellulose, Monoethanolamine, N-Dodecyl Sulfate, Purified Water

  • ACTIVE INGREDIENT

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

  • INDICATIONS & USAGE

    -Washing whenever a germicidal soap is required

    -Maximum degerming of hands

  • DOSAGE & ADMINISTRATION

    A. For Preoperative Washing by Operating Personnel

    1. Wet hands with water. Pour about 5 cc (1 teaspoonful) of PVP Scrub Solution on the palm of the hand and spread over both hands. Without adding more water, rub the Scrub thoroughly over all areas for about five minutes. Use brush if desired.

    2. Clean thoroughly under fingernails. Add a litle water and develop copious suds. Rinse thoroughly under running water. Complete the wash by scrubbing with another 5 cc of PVP Scrub Solution in the same way.

    B. For Preoperative Use on Patients

    After the skin area is shaved, wet it with water. Apply PVP Scrub Solution (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about five minutes. Rinse off by aid of sterile gauze saturated with water. The area may then be painted with PVP Scrub Solution and allowed to dry.

  • PRINCIPAL DISPLAY PANEL

    NDC# 68599-3501-1

    NDC # 68599-3501-2

    McKesson

    PVP scrub Solution USP

    7.5% Povidone Iodine

    Antiseptic Bactericide / Virucidal Sudsing Skin Cleanser

    Net Contents 16 fl oz (473 mL)

    12 bottles per case

    MFR# 037

    037 each037 Case

  • PRINCIPAL DISPLAY PANEL

    NDC # 68599-3501-5

    NDC# 68599-3501-6

    McKesson

    PVP scrub Solution USP

    7.5% Povidone Iodine

    Antiseptic Bactericide / Virucidal Sudsing Skin Cleanser

    Net Contents 1 gal (3.8 L)

    4 bottles per case

    MFR# 038

    038 each038 case

  • INGREDIENTS AND APPEARANCE
    PVP SCRUB SOLUTION 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-3501
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE7.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    LAURYL SULFATE (UNII: DIQ16UC154)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-3501-212 in 1 CASE03/03/2017
    1NDC:68599-3501-129.57 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68599-3501-64 in 1 CASE03/03/2017
    2NDC:68599-3501-515141.6 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/03/2017
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Degassa812771980manufacture(68599-3501)