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| Product NDC Code | 0132-8743 | ||||
|---|---|---|---|---|---|
| Drug Name | Summers eve |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | VAGINAL | ||||
| Dosage Form | DOUCHE | ||||
| RxCUI drug identifier | 312556, 898396 |
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| Application Number | part333E | ||||
| Labeler Name | C.B. Fleet Company, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each bottle when mixed with packet) Povidone-iodine 0.3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, edetate disodium, phosphoric acid*purified water, sodium benzoate, sodium hydroxide, sodium lauryl sulfate, sodium phosphate tribasic *may contain this ingredient
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use for temporary relief of minor vaginal irritation or itching
Purpose
Information about the drug product’s indications for use.Purpose Antimicrobial
Spl product data elements
Usually a list of ingredients in a drug product.SUMMERS EVE povidone-iodine PHOSPHORIC ACID SODIUM HYDROXIDE CITRIC ACID MONOHYDRATE EDETATE DISODIUM WATER SODIUM BENZOATE SODIUM LAURYL SULFATE SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS POVIDONE-IODINE IODINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Summer’s Eve Medicated Douche PRINCIPAL DISPLAY PANEL Summer’s Eve Medicated Douche
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of the reach of children . If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-787-6383
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if douching results in pain, soreness, swelling, redness, itching, excessive dryness or irritation symptoms continue after 7 days
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API