Label: MEDPRIDE PREP SOLUTION TOPICAL ANTISEPTIC MICROBICIDE- povidone-iodine solution

  • NDC Code(s): 52410-4114-5, 52410-4114-6
  • 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 April 10, 2023

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  • Active Ingredient

    Povidone Iodine, 10% (equivalent to 1% available Iodine)

  • Purpose

    Antiseptic

  • Uses

    • Health-care 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 eyes
    • As a first antiseptic longer than one week
    • On individuals who are allergic or sensitive to iodine
    • Apply over large areas of body
  • Discontinue use and call your doctor if

    • Irritation and redness develop and persists for more than 72 hours
    • Condition persists or get worse
  • Ask your doctor in case of

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
  • Keep out of reach of children

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

  • Directions

    For preparation of the skin prior to surgery:

    • Apply product to the operative site prior to surgery

    As a first aid antiseptic:

    • Clean the affected area
    • Apply a small amount of this product on the area 1-3 times daily
    • May be covered with a sterile bandage
    • If bandaged, let dry first
  • Inactive ingredients

    Citric Acid, Sodium Citrate, Glycerin, Tween 80, Disodium Phosphate, Purified Water

  • Principal Display Panel

    Principal Display & Drug Fact PanelPrincipal Display & Drug Fact Panel package 2

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE PREP SOLUTION  TOPICAL ANTISEPTIC MICROBICIDE
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-4114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-4114-5474 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2019
    2NDC:52410-4114-63785 mL in 1 JUG; Type 0: Not a Combination Product05/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/13/2019
    Labeler - Shield Line LLC (078518916)
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