Otc - Active Ingredient
Active ingredients Purpose
Benzalkonium Chloride 0.1% Antimicrobial
Avva
FDA Label NDC 68915-256
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 Avva (NDC 68915-256). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Image Of Back Of Box (Back)
Package Label.Principal Display Panel
Avva Vaginal Douche Gel with Benzalkonium Chloride0.18 fl oz 5.5 ml
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