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.

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Summers Eve povidone-iodine douche

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:


When and how to douche:

Other information

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

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)

Revised: 7/2020
Document Id: 26c73f2b-f79c-43a5-b4b7-6300debaf90f
Set id: 46f59721-0d24-4b42-ab3b-b250744da1e3
Version: 10
Effective Time: 20200703
 
C.B. Fleet Company, Inc.