Label: BETADINE- povidone-iodine spray

  • 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 January 31, 2011

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  • Drug Facts

    Active ingredient

    Povidone-iodine, 5% (0.5% available iodine).

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  • Purpose

    Antiseptic

    Uses

    Patient pre-operative skin preparation

    • for preparation of the skin prior to surgery
    • helps reduce bacteria that potentially can cause skin infection
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  • Warnings

    For external use only

    Do not use

    • in the eyes
    • If you are allergic to povidone-iodine or any other ingredients in this preparation

    When using this product

    • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
    • in pre-operative prepping, avoid “pooling” beneath the patient

    Stop use and ask a doctor if

    • irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • hold container about 4-6 inches from skin
    • spray desired area n allow to dry
    • may be bandaged
    • replace cap after use
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  • Other information

    • store at 25°C (77°F); excursions permitted between 15°–30°C (59°–86°F). Do not freeze.
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  • Inactive ingredients

    citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water

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  • SPL UNCLASSIFIED SECTION

    Dist. by: Purdue Products L.P., Stamford, CT 06901-3431
    301821-0B

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  • PRINCIPAL DISPLAY PANEL



    Betadine Spray
    NDC 67618-148-03

    Betadine Spray NDC 67618-148-03
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  • INGREDIENTS AND APPEARANCE
    BETADINE 
    povidone-iodine spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67618-148
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE .05 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67618-148-03 89 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/15/1992
    Labeler - Purdue Products LP (141916531)
    Establishment
    Name Address ID/FEI Business Operations
    Thatcher Company 041307356 MANUFACTURE
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