Summers Eve
Povidone-iodine
C.b. Fleet Company, Inc.
Human Otc Drug
NDC 0132-8743Summers Eve also known as Povidone-iodine is a human otc drug labeled by 'C.b. Fleet Company, Inc.'. National Drug Code (NDC) number for Summers Eve is 0132-8743. This drug is available in dosage form of Douche. The names of the active, medicinal ingredients in Summers Eve drug includes Povidone-iodine - 4 g/133mL . The currest status of Summers Eve drug is Active.
Drug Information:
| Drug NDC: | 0132-8743 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Summers Eve |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Povidone-iodine |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | C.b. Fleet Company, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Douche |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | POVIDONE-IODINE - 4 g/133mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | VAGINAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH NOT FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 10 May, 2002 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 12 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part333E |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | C.B. Fleet Company, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 312556
898396
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| NUI: | N0000175486
M0011640
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 85H0HZU99M
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class EPC: | Antiseptic [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Iodine [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 0132-8743-02 | 133 mL in 1 BOTTLE (0132-8743-02) | 10 May, 2002 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antimicrobial
Product Elements:
Summers eve povidone-iodine povidone-iodine iodine phosphoric acid sodium hydroxide citric acid monohydrate edetate disodium water sodium benzoate sodium lauryl sulfate sodium phosphate, tribasic, anhydrous
Indications and Usage:
Use for temporary relief of minor vaginal irritation or itching
Warnings:
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.
Do Not Use:
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.
Dosage and Administration:
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
Stop Use:
Stop use and ask a doctor if douching results in pain, soreness, swelling, redness, itching, excessive dryness or irritation symptoms continue after 7 days
Package Label Principal Display Panel:
Principal display panel summerâs eve medicated douche principal display panel summerâs eve medicated douche
Further Questions:
Questions? 1-866-787-6383