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Guardian

Eastern Century Pharmaceuticals
Eastern Century Pharmaceuticals

Guardian Gel Vaginal Douche




FULL PRESCRIBING INFORMATION

Benzalkonium Chloride 0.1%

antimicrobial

  • 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.

Discontinue use if

any burning, itching, or irritation of the vagina occur during use.

Keep out of reach of children.

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.

Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, Sodium Hydroxide, Water

Store at room temperature in a cool, dry place.

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.

Two years after printed date of manufacture.

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.

Eastern Century Pharmaceuticals, US (ECP)
2345 Oakwood Dr., Prescott, AZ 86305 USA
Made in the USA

Guardian Gel

Vaginal Douche Gel with Benzalkonium Chloride


0.18 fl oz. 5.5 ml

Guardian

Guardian

Guardian

Benzalkonium Chloride DOUCHE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68915-280
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
benzalkonium chloride 1 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER 934
GLYCERIN
HYPROMELLOSES
METHYLPARABEN
SODIUM HYDROXIDE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68915-280-01 5.5 in 1 BOTTLE
2 NDC:68915-280-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part333A 2011-05-23


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Be sure to consult your doctor before taking any medication!
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