1. Home
  2. Labeler Index
  3. Eastern Century Pharmaceuticals
  4. 68915-280
  5. Label Information: Guardian Vaginal

FDA Label for Guardian Vaginal

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES:
    4. WARNINGS:
    5. STOP USE AND ASK A DOCTOR IF:
    6. DISCONTINUE USE IF
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS:
    9. INACTIVE INGREDIENTS:
    10. STORAGE:
    11. OTHER INFORMATION:
    12. EXPIRATION DATE:
    13. PRECAUTIONS:
    14. DISTRIBUTED BY:
    15. FRONT LABEL
    16. BACK LABEL

Guardian Vaginal Product Label

The following document was submitted to the FDA by the labeler of this product Eastern Century Pharmaceuticals. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Benzalkonium Chloride 0.1%


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.