FDA Label for Avva

View Indications, Usage & Precautions

Avva Product Label

The following document was submitted to the FDA by the labeler of this product Avva International Llc. 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
Benzalkonium Chloride  0.1%    


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


Package Label.Principal Display Panel




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