Label: POVIDONE IODINE PREP SWABSTICK- povidone iodine solution

  • NDC Code(s): 60913-051-01, 60913-051-03
  • Packager: PHOENIX HEALTHCARE SOLUTIONS, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2024

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  • Active ingredient

    Povidone Iodine USP 10% v/v

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

    Discontinue use if irritation and redness develop.

    Consult a doctor in case of

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and consult a doctor

    if the condition persists or gets worse.

    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

    • clean the affected area
    • apply a small amount of this product on the area

    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
    • may be covered with a sterile bandage
    • if bandaged, let dry first.
  • Other information

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

  • Inactive ingredients:

    citric acid, glycerin, Makon 8, purified water, sodium hydroxide

  • Principal Display Panel

    NDC 60913-051-01

    Phoenix Healthcare Solutions LLC

    "An Innovative Medical Manufacturer"

    Povidone Iodine Swabsticks

    10% Povidone Iodine, USP

    For Professional and Hospital Use

    Antispetic/ Germicide

    50 Pouches Per Box

    1 Swabstick Per Pouch

    Label

    NDC 60913-051-03

    Phoenix Healthcare Solutions LLC

    "An Innovative Medical Manufacturer"

    Povidone Iodine Swabsticks

    10% Povidone Iodine, USP

    For Professional and Hospital Use

    Antispetic/ Germicide

    25  Pouches Per Box

    3  Swabsticks Per Pouch

    Label 1

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP  SWABSTICK
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60913-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60913-051-0150 in 1 BOX06/23/2015
    11 in 1 POUCH
    11 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:60913-051-0325 in 1 BOX06/23/2015
    23 in 1 POUCH
    21 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/23/2015
    Labeler - PHOENIX HEALTHCARE SOLUTIONS, LLC (079146847)
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