Home > Drugs A-Z > Aplicare Povidone Iodine

Aplicare Povidone Iodine (Aplicare, Inc.)

Available Formats

Dosage Form Package Information Links
GEL 120 g in 1 BOTTLE (52380-1738-5) Label Information
GEL 120 g in 1 BOTTLE (52380-1738-4) Label Information

Complete Aplicare Povidone Iodine Information

  • ACTIVE INGREDIENT

    Povidone-iodine USP 10%

    Antiseptic


  • 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.


  • WARNINGS

    Do not use if allergic to iodine

    For external use only

    Do not use in eyes

    Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.


  • STOP USE

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

  • ASK DOCTOR

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

  • QUESTIONS

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


  • INDICATIONS & USAGE

    Use

    antiseptic skin preparation

    single use when used for patient preoperative skin preparation and/or preinjection indications


  • DOSAGE & ADMINISTRATION

    Directions apply locally as needed.


  • OTHER SAFETY INFORMATION

    Other information

    1% titratable iodine

    latex free

    for professional or professional use only


  • INACTIVE INGREDIENT

    disodium phosphate

    glycerin

    hydroxyethylcellulose

    nonoxynol-10

    simethicone

    water


  • PRINCIPAL DISPLAY PANEL

    APLICARE

    POVIDONE-IODINE GEL

    ANTISEPTIC

    NON-STERILE SOLUTION

    52380-1138 PVP Gel


  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE IODINE 
    povidone iodine gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-1738
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-1738-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/1998
    2 NDC:52380-1738-5 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/01/1998
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/01/1998
    Labeler - Aplicare Products, LLC. (081054904)
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare Products, LLC. 081054904 manufacture(52380-1738) , repack(52380-1738)