Label: MEDPRIDE SWABSTICKS- povidone iodine solution

  • 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 November 18, 2019

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  • Active Ingredient

    Povidone Iodine 10% v/v

    (equivalent to 1% titratable iodine)

  • Purpose

    Antiseptic

  • Uses

    ■ health care antiseptic for preparation of the skin prior to surgery

    ■ first aid antiseptic to help prevent the risk of skin 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

    Discontinue use

    ■ if irritation and redness develops

  • Consult a doctor in case of

    ■ deep puncture wounds

    ■ animal bites

    ■ serious burns

  • Stop use and ask a doctor if

    ■ if the condition persist or gets worse

  • Keep out of reach of children

    If swallowed contact a doctor or Poison Control Center right away.

  • Directions

    ■ for preparation of the skin prior to surgery, clean the affected area, remove the swab by stick, apply to the operative site prior to surgery

    ■ for use as a first aid antiseptic, clean the affected area, apply a small amount of this product on the area 1-3 times daily

  • Other Information

    ■ store at room temperature:15-30C (59-86F)

  • Inactive Ingredients

    citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE  SWABSTICKS
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-6141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-8 (UNII: OSD2GAP7HY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-6141-150 in 1 BOX; Type 0: Not a Combination Product01/01/2019
    2NDC:52410-6141-375 in 1 BOX; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2014
    Labeler - Shield Line LLC (078518916)
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