SUMMERS EVE- povidone-iodine douche

SUMMERS EVE by

Drug Labeling and Warnings

SUMMERS EVE by is a Otc medication manufactured, distributed, or labeled by C.B. Fleet Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Stop use and ask a doctor if

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

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)