Otc - Active Ingredient
Active ingredients
Benzalkonium Chloride 0.1%
Avva
FDA Label NDC 42891-4148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avva International Llc for the product Avva (NDC 42891-4148). 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, general precautions, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Antimicrobial
Otc - Keep Out Of Reach Of Children
Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away
Indications & Usage
Uses: for vaginal cleansing. Kills germs.
Directions:
· take of any plastic around the tube
· remove the small plastic cap from the top of the applicator
· gently insert the end with small hole of the applicator deep into the vagina, while in this position gently push the plunger of the applicator to release the gel
· remove the applicator and discard it in a waste container
· children under 12 years of age: Ask a doctor
General Precautions
Do not use if the package seal is broken
Warnings
Warnings:
For external use only
Do not use
· more often than twice weekly unless directed by physician
· to prevent pregnancy
· during pregnancy
· if you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)
· to prevent STD or PID
When using this product keep out of eyes. Rinse with water to remove
Stop use and ask doctor if rash, irritation, swelling, pain or redness develops
Dosage & Administration
Do not use more often than twice weekly unless directed by physician
Inactive Ingredient
Inactive Ingredients:
allantoin, carbomer, glycerin, hydroxyethylcellulose, sodium hydroxide, water
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