Label: HENRY SCHEIN POVIDONE-IODINE PREP PAD- povidone-iodine swab

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 13, 2023

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  • Active ingredient

    Povidone Iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    For preparation of the skin prior to surgery

  • Warnings

    For external use only.

    Do not apply to persons allergic to iodine.

    Do not use in the eyes.

    • Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

    • Keep out of reach of children
    • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
  • Directions

    Clean area. Apply to the operative site prior to surgery

  • Other information

    • 1 % titratable iodine. Store at ambient temperatures
  • Inactive ingredients

    alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

  • Principal Display Panel - 0.5 mL Item Label

    NDC 0404-0121-01

    HENRY SCHEIN ®

    REF 570-1543

    POVIDONE-IODINE
    PREP PAD

    10% Povidone-Iodine

    For Professional and Hospital Use

    Not Made with Natural Rubber Latex

    HENRY SCHEIN
    SEAL OF EXCELLENCE ®

    1/Pouch

    Principal Display Panel - 0.5 mL Item Label
  • INGREDIENTS AND APPEARANCE
    HENRY SCHEIN POVIDONE-IODINE PREP PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0121
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0404-0121-018000 in 1 CASE10/22/2019
    10.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/22/2019
    Labeler - Henry Schein, Inc. (012430880)