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  5. Label Information: Summers Eve

FDA Label for Summers Eve

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH BOTTLE WHEN MIXED WITH PACKET)
    2. USE
    3. WARNINGS
    4. DO NOT USE
    5. KEEP OUT OF THE REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS?
    10. STOP USE AND ASK A DOCTOR IF

Summers Eve Product Label

The following document was submitted to the FDA by the labeler of this product C.b. Fleet Company, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient (In Each Bottle When Mixed With Packet)



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


Use



For temporary relief of minor vaginal irritation or itching.


Warnings



For vaginal use only


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

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.
  • 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.

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, purified water, sodium benzoate, sodium lauryl sulfate, trisodium phosphate


Questions?



1-866-787-6383


Stop Use And Ask A Doctor If



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

* Please review the disclaimer below.