Label: PVP IODINE PREP PAD MEDIUM AND LARGE- providone iodine swab
PVP IODINE PREP SWABSTICK ONES AND THREES- providone iodine stick

  • NDC Code(s): 10819-3883-1, 10819-3883-3, 10819-3885-1, 10819-3885-2
  • Packager: Professional Disposables International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2023

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  • Active ingredient

    Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

  • Purpose

    Antiseptic

  • Uses

    • A broad spectrum antiseptic for topical application for preparation of the skin prior to surgery.
  • Warnings

    For external use only

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

    Discontinue use if irritation and redness develop. If condition persist for more than 72 hours or gets worse, consult a healthcare provider

  • Directions

    For preparation of the skin prior to surgery

    • clean the treatment area
    • remove swab
    • apply to the operative site prior to surgery
    • allow to dry

  • Other information

    • Store at room temperature
    • Avoid excessive heat
  • Inactive ingredients

    Purified Water, Sodium Hydroxide

  • Do not use

    Do not use

    - in the eyes, nose or mouth
    - on individuals who are allergic or sensitive to iodine
    - over large areas of the body
    - longer than one week unless directed by a doctor

  • Consult a healthcare provider

    Consult a healthcare provider in case of

    - deep or puncture wounds

    - animal bites

    - serious burns

  • Keep out of reach of children

    Keep out of reach of children.

  • Principal Display Panel

    Packet 1 swabstick

    Packet 1

    Box 1 swabstick

    Box 1

    Packet 3 swabsticks

    Packet 3

    Box 3 swabsticks

    box 3

    Packet med

    Packet med revised

    Box med

    Packet med box revised

    Packet large

    packet l

    Box large

    box l

  • INGREDIENTS AND APPEARANCE
    PVP IODINE PREP PAD  MEDIUM AND LARGE
    providone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3883
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-3883-1100 in 1 BOX01/01/1978
    10.8 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:10819-3883-3100 in 1 BOX01/01/197803/25/2024
    22.2 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/1978
    PVP IODINE PREP SWABSTICK  ONES AND THREES
    providone iodine stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3885
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-3885-150 in 1 BOX01/01/1978
    12.5 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:10819-3885-225 in 1 BOX01/01/1978
    27 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/1978
    Labeler - Professional Disposables International, Inc. (800777117)
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