Active Ingredient
Benzalkonium Chloride 0.1%
Guardian Douche
FDA Label NDC 68915-280
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eastern Century Pharmaceuticals for the product Guardian (NDC 68915-280). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses:, warnings:, stop use and ask a doctor if:, discontinue use if, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
antimicrobial
Uses:
- for vaginal cleansing. Kills germs.
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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 Ingredients:
Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, Sodium Hydroxide, Water
Storage:
Store at room temperature in a cool, dry place.
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.
Expiration Date:
Two years after printed date of manufacture.
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.
Distributed By:
Eastern Century Pharmaceuticals, US (ECP)
One Pierce Place, #475W, Itasca, IL 60143 USA
Made in the USA
Front Label
Guardian Gel
Vaginal Douche Gel with Benzalkonium Chloride
0.18 fl oz. 5.5 ml
* Please review the disclaimer below.
