Label: MEDPRIDE POVIDONE IODINE SCRUB SOLUTION SKIN CLEANSER- povidone-iodine solution

  • NDC Code(s): 52410-4116-5, 52410-4116-6
  • Packager: Shield Line LLC
  • 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 June 12, 2023

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  • Active Ingredient

    Povidone Iodine, 7.5% (equivalent to .75% available Iodine)

  • Purpose

    Antiseptic

  • Uses

    • Washing whenever a germicidal soap is required
    • Maximum degerming of the hands
  • WARNINGS:

    For External Use Only

  • Keep out of reach of children

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

    • Apply necessary quantity Degasa Surgical Scrub on area to wash on patients for preoperative or for operating personnel.
    • Distributing thoroughly Degasa Surgical Scrub on the desired area, rubbing at least 5 minutes.
    • On patients, rinse off with a sterile gauze saturated with water. On operating personnel, rinse the hands under running water, clean under fingernails use brush if desired.
    • On operations personnel complete disinfection with another wash with the same way.
  • Inactive ingredients

    Disodium Hydrogen Phosphate,Citric Acid, Purified Water

  • Principal Display Panel

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE POVIDONE IODINE SCRUB SOLUTION  SKIN CLEANSER
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-4116
    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 ACETATE (UNII: DSO12WL7AU)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-4116-5474 mL in 1 BOTTLE; Type 0: Not a Combination Product05/14/2019
    2NDC:52410-4116-63785 mL in 1 JUG; Type 0: Not a Combination Product05/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/14/2019
    Labeler - Shield Line LLC (078518916)
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