BETADINE (POVIDONE-IODINE) SPRAY [PURDUE PRODUCTS LP]

BETADINE (POVIDONE-IODINE) SPRAY [PURDUE PRODUCTS LP]
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NDC 67618-148-03
Set ID 2f07daa4-86ee-4a2d-ae3a-c3a7b574ed10
Category HUMAN OTC DRUG LABEL
Packager Purdue Products LP
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333A
  • 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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