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

  • 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 March 5, 2021

If you are a consumer or patient please visit this version.

  • 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 not finalpart333E10/22/2019
    Labeler - Henry Schein, Inc. (012430880)