FDA Label for Avva Vaginal

View Indications, Usage & Precautions

Avva 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.

Otc - Active Ingredient



Active ingredients                             Purpose

Benzalkonium Chloride  0.1%          Antimicrobial


Otc - Purpose



Uses: for vaginal cleansing. Kills germs.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children


Indications & Usage



Stop use and ask doctor if: Rash or irritation and redness develops.

Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. 

Do not douche to prevent pregnancy

During pregnancy

If you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)

To self treat or prevent a STD or PID

After exposure to STD 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 a serious condition.

Warnings



If swallowed, get medical help or contact a poison control center right away. External use only Do not use in eyes.

Dosage & Administration



Directions

Insert the gel into the vagina when cleansing is desired, one unit (5.5 ml) 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 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



Inactive Ingredients

Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, sodium hydroxide, water




Package Label.Principal Display Panel



Avva Vaginal Douche Gel with Benzalkonium Chloride0.18 fl oz  5.5 ml

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