Label: APLICARE TOTAL JOINT PREP - povidone-iodine

  • NDC Code(s): 52380-0001-3, 52380-3101-5, 52380-7310-0
  • Packager: Aplicare, Inc.
  • 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 6, 2012

If you are a consumer or patient please visit this version.

  • Active ingredient

    Povidone-iodine USP
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  • Purpose

    Antiseptic

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  • Use

    antiseptic skin preparation
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  • Warnings

    Do not use

    • if allergic to iodine
    • in the eyes
    For external use only

    Avoid pooling beneath patient
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  • ASK DOCTOR

    Ask a doctor before use if injuries are
    • deep or puncture wounds
    • serious burns
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  • STOP USE

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

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  • Directions

    apply locally as needed
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  • Other information

    • 1 percent titratable iodine
    • latex free
    • for hospital or professional use only
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  • Inactive ingredients

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

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  • QUESTIONS

    1-800-760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

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  • PRINCIPAL DISPLAY PANEL

    THREE POVIDONE-IODINE SWABSTICKS

    Three 4-inch saturated swabsticks

    STERILE unless opened or damaged.

    Three Povidone-iodine Swabsticks


    3/4 FLUID OUNCE POVIDONE-IODINE SOLUTION

    0.75 Fl. oz. (22.5 mL)

    STERILE unless opened or damaged.

    3/4 Fluid Ounce Povidone-iodine Solution



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  • PRINCIPAL DISPLAY PANEL

    Total Joint Prep Kit

    Total Joint Prep Kit

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  • INGREDIENTS AND APPEARANCE
    APLICARE TOTAL JOINT PREP  
    povidone-iodine kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-7310
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-7310-0 50 in 1 CASE
    1 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKET 6.5 mL
    Part 2 1 PACKET 30 mL
    Part 1 of 2
    APLICARE POVIDONE-IODINE TRIPLES 
    povidone-iodine solution
    Product Information
    Item Code (Source) NDC:52380-3101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 9.8 g  in 96.4 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-3101-5 6.5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1998
    Part 2 of 2
    APLICARE POVIDONE-IODINE  
    povidone-iodine solution
    Product Information
    Item Code (Source) NDC:52380-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 9.8 g  in 96.4 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0001-3 30 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1984
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 12/01/2011
    Labeler - Aplicare, Inc. (107255002)
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare, Inc. 107255002 relabel, manufacture
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