OTC Medication Information: SUMMERS EVE

SUMMERS EVE- povidone-iodine douche
C.B. Fleet Company, Inc.

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 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
MedicatedDouche

PRINCIPAL DISPLAY PANEL
Summer’s Eve
Medicated
Douche
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SUMMERS EVE povidone-iodine douche
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-8743
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 4 g in 133 mL
Inactive Ingredients
Ingredient Name Strength
PHOSPHORIC ACID
SODIUM HYDROXIDE
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
WATER
SODIUM BENZOATE
SODIUM LAURYL SULFATE
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0132-8743-02 133 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part333E 05/10/2002
Labeler — C.B. Fleet Company, Inc. (003119054)

Revised: 07/2020 C.B. Fleet Company, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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