Label: FRESH AND PURE- povidone-iodine

  • 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 26, 2012

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

  • Active ingredient (in each bottle when mixed with packet)

    Povidone-iodine 0.3%

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  • Purpose

    Antimicrobial

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  • Use

    for temporary relief of minor vaginal irritation or itching

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  • Warnings

    For vaginal use only

    Do not use

    • if you have an iodine sensitivity
    • to prevent pregnancy
    • during pregnancy
    • if you have symptoms of pelvic inflammatory disease (PID), such as lower abdominal pain, fever, chills, nausea, vomiting, and/or a pus-like yellow cervical discharge; see a doctor right away
    • if you have symptoms of sexually transmitted diseases (STD), such as vaginal discharge of an unusual amount, color, or odor, painful and/or frequent urination, genital sores or ulcers; see a doctor right away
    • to self-treat or prevent an STD or PID
    • after exposure to an STD

    Stop use and ask a doctor if

    • douching results in pain, soreness, swelling, redness, itching, excessive dryness, or irritation
    • symptoms continue after 7 days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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  • Directions

    Preparing the douche:

    • remove cap, discard
    • carefully open the medicated packet and pour into the douche bottle. The contents can stain certain materials
    • screw nozzle onto the bottle
    • swirl bottle gently to mix

    When and how to douche:

    • use once daily for seven days, even if symptoms disappear sooner
    • gently insert nozzle into your vagina, no more than 3 inches, and slowly squeeze bottle
    • do not close the vaginal opening; douching solution should flow freely out of vagina
    • use while sitting on the toilet, in the tub, or while standing in the shower
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  • Other information

    • store at 20-25°C (68-77°F)
    • an association has been reported between douching and pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. It is not currently known whether douching is causally related to these conditions, but women should be aware of this association.
    • see a doctor right away if you have symptoms of PID or STD
    • tamper evident: carton and douche concentrate packet sealed for safety. Do not use if printed seal on carton top or bottom flap is broken or missing, or packet is leaking.
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  • Inactive ingredients

    dibasic sodium phosphate, glycerin, hydrogen peroxide, nonoxynol-10, phosphoric acid, purified water 

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  • Questions or comments?

    1-800-367-4477

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  • Package/Label Principal Display Panel

    Compare to Summer’s Eve® Douche Active Ingredient

    fresh & pure

    douche

    MEDICATED

    Antimicrobial

    Povidone-Iodine

    For Relief of Minor Vaginal Irritation & Itching

    # {“#” must represent number of bottles in carton}

    Fresh & Pure Douche Carton Image 1

    Fresh & Pure Douche Carton Image 1

    Fresh & Pure Douche Carton Image 2

    Fresh & Pure Douche Carton Image 2

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  • INGREDIENTS AND APPEARANCE
    FRESH AND PURE 
    povidone-iodine kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-0110
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0113-0110-36 1 in 1 CARTON
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 2 PACKET 8 mL
    Part 2 2 BOTTLE 266 mL
    Part 1 of 2
    MEDICATED POVIDONE-IODINE 
    povidone-iodine solution, concentrate
    Product Information
    Route of Administration VAGINAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE .3 g  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 4 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/09/2009
    Part 2 of 2
    QUALITY DISPOSABLE DOUCHE 
    inactive douche
    Product Information
    Route of Administration VAGINAL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 133 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/09/2009
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/09/2009
    Labeler - L Perrigo Company (006013346)
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