Label: SUMMERS EVE- povidone-iodine douche

  • NDC Code(s): 0132-8743-02
  • Packager: C.B. Fleet Company, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 August 5, 2013

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

    Povidone-Iodine 0.3%...............Antimicrobial

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  • Use

    For temporary relief of minor vaginal irritation or itching.

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  • Warnings

    For vaginal use only

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  • Do not use

    Do not use

    • if you have an iodine sensitivity
    • to prevent pregnancy
    • if you are trying to become pregnant or 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 unuusal 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
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  • Keep out of the reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    Preparing to douche:

    • remove sanitary overwrap and unscrew nozzle cap.
    • carefully open the medicated packet and pour into the douche bottle. The contents can stain certain materials.
    • screw the nozzle cap back onto the bottle.
    • swirl bottle gently to mix. Hold cap of bottle with one hand and grasp Comfortip nozzle firmly with the other hand.
    • pull nozzle straight up until it clicks in place. Douche is not ready for use until you hear this click.
    • after mixing, use within one hour.

    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

    • 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.
    • bottle overwrapped and douche concentrate packet sealed for your protection. Do not use if overwrap imprinted "FRESHNESS HAS NEVER BEEN SIMPLER" is torn or missing, or packet is leaking.
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  • Inactive Ingredients

    citric acid, edetate disodium, purified water, sodium benzoate, sodium lauryl sulfate, trisodium phosphate

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  • Questions?

    1-866-787-6383

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  • Stop use and ask a doctor if

    • douching results in pain, soreness, swelling, redness, itching, excessive dryness or irritation
    • symptoms continue after 7 days
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  • INGREDIENTS AND APPEARANCE
    SUMMERS EVE 
    povidone-iodine douche
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-8743
    Route of Administration VAGINAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 4 g  in 133 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, TRIBASIC ANHYDROUS (UNII: SX01TZO3QZ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0132-8743-02 133 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part330 05/10/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)
    Establishment
    Name Address ID/FEI Business Operations
    C.B. Fleet Company, Inc. 003119054 manufacture(0132-8743)
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