Label: HENRY SCHEIN POVIDONE-IODINE SWABSTICKS- 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

    Patient preoperative skin preparation: Helps to reduce bacteria that potentially can cause skin infection.

  • Warnings

    For external use only.

    Do not use

    • if allergic to iodine
    • in the eyes

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burn

    Stop use and ask a doctor if

    • infection occurs
    • redness, irritation or swelling develops

    Keep out of reach of children.

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

  • Directions

    Apply product to skin as needed

  • Other information

    • 1 % titratable iodine
    • Avoid excessive heat
    • Store at room temperature
    • For hospital or professional use only
    • Not made with natural rubber latex
  • Inactive ingredients

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

  • Questions?

    1-800-472-4346

  • Principal Display Panel - 2.3 mL Item Label

    NDC 0404-0119-01

    HENRY SCHEIN ®

    REF 570-1549

    POVIDONE-IODINE
    SWABSTICKS

    10% Povidone-Iodine
    Single Packs

    1 Swabstick/Pack

    Do not re-use

    Principal Display Panel - 2.3 mL Item Label
  • INGREDIENTS AND APPEARANCE
    HENRY SCHEIN POVIDONE-IODINE SWABSTICKS 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-0119
    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:0404-0119-011000 in 1 CASE10/22/2019
    11 in 1 POUCH
    12.3 mL in 1 APPLICATOR; 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)