AVVA- benzalkonium chloride gel

AVVA by

Drug Labeling and Warnings

AVVA by is a Otc medication manufactured, distributed, or labeled by AVVA International LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Benzalkonium Chloride  0.1%    

PURPOSE

Purpose
Antimicrobial

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AVVA 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42891-4148
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	100 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42891-4148-0	6 in 1 BOX	03/28/2012
1	NDC: 42891-4148-1	5.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/28/2012

Labeler - AVVA International LLC (020023853)