Label: GUARDIAN VAGINAL- benzalkonium chloride douche
- NDC Code(s): 68915-280-01, 68915-280-02
- Packager: Eastern Century Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Benzalkonium Chloride 0.1%Close
- for vaginal cleansing. Kills germs.
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.
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, WaterClose
Store at room temperature in a cool, dry place.Close
- 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.Close
- Expiration Date:
Two years after printed date of manufacture.Close
Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. Guardian GelTM is an effective douche when used according to the directions.Close
- Distributed by:
Eastern Century Pharmaceuticals, US (ECP)Close
2345 Oakwood Dr., Prescott, AZ 86305 USA
Made in the USA
- Front Label
Vaginal Douche Gel with Benzalkonium Chloride
0.18 fl oz. 5.5 ml
- Back Label
- INGREDIENTS AND APPEARANCE
benzalkonium chloride douche
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68915-280 Route of Administration VAGINAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER 934 (UNII: Z135WT9208) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSES (UNII: 3NXW29V3WO) METHYLPARABEN (UNII: A2I8C7HI9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68915-280-02 1 in 1 BOX 1 NDC:68915-280-01 5.5 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/23/2011 Labeler - Eastern Century Pharmaceuticals (966499373) Registrant - Eastern Century Pharmaceuticals (966499373) Establishment Name Address ID/FEI Business Operations Lifetech Resources, LLC 622559110 manufacture(68915-280)