Label: POVIDONE-IODINE SWABSTICKS SINGLES- povidone-iodine swab
POVIDONE-IODINE SWABSTICKS TRIPLES- povidone-iodine swab

  • NDC Code(s): 53329-945-09, 53329-945-29, 53329-946-02, 53329-946-75
  • 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 September 28, 2022

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  • Active ingredient

    Povidone-Iodine, 10.0% w/v

  • Purpose

    Antiseptic

  • Uses

    • for preparation of the skin prior to surgery
    • 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 one week unless directed by a doctor
    • on individuals who are allergic or sensitive to iodine
    • or apply over large areas of the body

    Stop use and ask a doctor

    • irritation and redness develop
    • condition persists for more than 72 hours
    • In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

    Keep out of reach of children.

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

  • Directions

    • Clean the affected area.
    • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery
    • For first aid antiseptic: 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

    • protect from freezing., avoid excessive heat
  • Inactive ingredients

    citric acid, disodium phosphate, purified water

  • Manufacturing Information

    Manufactured for:
    Medline Industries, LP
    Three Lakes Drive, Northfield, IL 60093 USA
    Made in China
    www.medline.com
    1-800-MEDLINE (633-5463)
    REF: MDS093901
    V1 RF22LPD

  • Package Label

    Label V1 RF22LPD

  • Tiple Swab Package Label

    label 3

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE  SWABSTICKS SINGLES
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-945
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-945-2950 in 1 BOX12/12/2018
    11 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53329-945-091 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  SWABSTICKS TRIPLES
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-946
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-946-7525 in 1 BOX12/12/2018
    1NDC:53329-946-023 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:53329-946-023 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
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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