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| Product NDC Code | 68915-280 | ||||
|---|---|---|---|---|---|
| Drug Name | Guardian vaginal |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | VAGINAL | ||||
| Dosage Form | DOUCHE | ||||
| RxCUI drug identifier | 1111013 | ||||
| Application Number | M003 | ||||
| Labeler Name | Eastern Century Pharmaceuticals | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Benzalkonium Chloride 0.1%
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: Insert the gel into the vagina when cleansing is desired, one unit (5.5ml) each time. Please read the following instructions carefully before use. 1. Take off any plastic around the tube. 2. Remove the small plastic tip from the top of the applicator. 3. Gently insert the small end of the applicator deep into the vagina. While in this position, squeeze the entire contents of the applicator to release the gel. Remove the applicator and discard it in a waste container. Do not use this product if the package seal is broken. Children under 12 years of age: ask doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, Sodium Hydroxide, Water
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.Uses: for vaginal cleansing. Kills germs.
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.Guardian Vaginal Benzalkonium Chloride CARBOMER 934 GLYCERIN HYPROMELLOSES METHYLPARABEN SODIUM HYDROXIDE WATER BENZALKONIUM CHLORIDE BENZALKONIUM
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.Front Label Guardian Gel Vaginal Douche Gel with Benzalkonium Chloride 0.18 fl oz. 5.5 ml Image of Front Label
Back Label Image of BackLabel
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.Expiration Date: Two years after printed date of manufacture.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop use and ask a doctor if: Rash and irritation and redness develops. Discontinue use if any burning, itching, or irritation of the vagina occur during use. Keep out of reach of children.
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 reach of children.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.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 casually 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Distributed by: Eastern Century Pharmaceuticals, US (ECP) One Pierce Place, #475W, Itasca, IL 60143 USA Made in the USA
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.Discontinue use if any burning, itching, or irritation of the vagina occur during use. Keep out of reach of children.
Storage and handling
Information about safe storage and handling of the drug product.Storage: Store at room temperature in a cool, dry place.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.Precautions: Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. Guardian Gel TM is an effective douche when used according to the directions.
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: Wash and douche with water. Do not Douche to prevent pregnancy. During pregnancy. If you have symptoms of pelvic inflammatory disease (PID) or a sexually transmitted disease (STD). To self-treat or prevent a STD or PID. After exposure to a STD Stop using this product stop using this product and consult a doctor if douching results in pain, soreness, swelling, redness, itching excessive dryness or irritation, or symptoms continue after 7 days. These may indicate serious condition. If swallowed, get medical help or contact a Poison Control Center right away. External use only. Do not use in eyes. Stop use and ask a doctor if: Rash and irritation and redness develops. Discontinue use if any burning, itching, or irritation of the vagina occur during use. Keep out of reach of children.
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