Label: POVIDONE-IODINE PREP PADS MEDIUM- povidone-iodine cloth
POVIDONE-IODINE PREP PADS MEDIUM BULK- povidone-iodine cloth

  • NDC Code(s): 53329-940-09, 53329-940-97, 53329-941-09, 53329-941-30
  • Packager: Medline Industries, LP
  • 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 August 21, 2023

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  • Active ingredient

    Povidone-Iodine, 10% w/w

  • Purpose

    Antiseptic

  • Uses

    • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • Warnings

    For external use only.

    Do not use

    • in the eyes
    • longer than 1 week unless directed by a physician
    • on individuals who are allergic or sensitive to iodine
    • or apply over large areas of the body

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours
    • in case of deep or puncture wounds, animal bites or serious burns

    Keep out of reach of children.

    If swallowed, get medical assistance or immediately contact a Poison Control Center.

  • Directions

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily.
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • do not flush
    • protect from freezing, avoid excessive heat
  • Inactive ingredients

    citric acid, disodium phosphate, water

  • Principal Display Panel

    PDP

  • Principal Display Panel

    PDP2

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE  PREP PADS MEDIUM
    povidone-iodine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-941
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-941-30100 in 1 BOX01/11/2019
    1NDC:53329-941-091 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53329-941-091 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2007
    POVIDONE-IODINE  PREP PADS MEDIUM BULK
    povidone-iodine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-940
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-940-973000 in 1 CASE01/11/201905/31/2022
    11 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53329-940-091 mL in 1 PACKET; Type 0: Not a Combination Product01/01/200705/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/200705/31/2022
    Labeler - Medline Industries, LP (025460908)
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