Label: SUMMERS EVE- povidone-iodine douche

  • NDC Code(s): 0132-8743-02
  • Packager: C.B. Fleet Company, Inc.
  • 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 July 3, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Povidone-iodine 0.3%

  • Purpose

    Antimicrobial

  • Use

    for temporary relief of minor vaginal irritation or itching

  • Warnings

    For vaginal use only

    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 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 the reach of children.

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

  • Directions

    Preparing to douche:

    • remove sanitary overwrap and unscrew nozzle cap
    • hold and squeeze foil packet just below notch. Tear off at notch. Carefully insert tip into 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 up to three days
    • 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
  • 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.
  • Inactive ingredients

    citric acid, edetate disodium, phosphoric acid*purified water, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, sodium phosphate tribasic

    *may contain this ingredient

  • Questions?

    1-866-787-6383

  • PRINCIPAL DISPLAY PANEL

    Summer’s Eve
    Medicated
    Douche

    PRINCIPAL DISPLAY PANEL
Summer’s Eve
Medicated
Douche

  • INGREDIENTS AND APPEARANCE
    SUMMERS EVE 
    povidone-iodine douche
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0132-8743
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE4 g  in 133 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0132-8743-02133 mL in 1 BOTTLE; Type 0: Not a Combination Product05/10/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E05/10/2002
    Labeler - C.B. Fleet Company, Inc. (003119054)