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

Drug Label Information

Updated December 11, 2024

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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 Drug505G(a)(3)01/01/2007
    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 Drug505G(a)(3)01/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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