NDC 0132-8743 Summers Eve

Povidone-iodine

NDC Product Information

Summers Eve with NDC 0132-8743 is a a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Summers Eve is povidone-iodine. The product's dosage form is douche and is administered via vaginal form.

Labeler Name: C.b. Fleet Company, Inc.

Dosage Form: Douche - A liquid preparation, intended for the irrigative cleansing of the vagina, that is prepared from powders, liquid solutions, or liquid concentrates and contains one or more chemical substances dissolved in a suitable solvent or mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Summers Eve Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POVIDONE-IODINE 4 g/133mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Vaginal - Administration into the vagina.
  • Vaginal - Administration into the vagina.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: C.b. Fleet Company, Inc.
Labeler Code: 0132
FDA Application Number: part333E What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-10-2002 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Summers Eve Product Label Images

Summers Eve Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 useif you have an iodine sensitivityto prevent pregnancyif you are trying to become pregnant or during pregnancyif 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 awayif 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 awayto self-treat or prevent an STD or PIDafter 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 irritationsymptoms continue after 7 days

* Please review the disclaimer below.