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AVVA

AVVA International LLC

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients                            
Benzalkonium Chloride  0.1%    

Purpose

Purpose
Antimicrobial

Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away

Uses

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


Do not use

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

Do not use more often than twice weekly unless directed by physician

Inactive Ingredients:
allantoin, carbomer, glycerin, hydroxyethylcellulose, sodium hydroxide, water

AVVA

AVVA

Benzalkonium chloride GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42891-4148
Route of Administration VAGINAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
benzalkonium chloride 100 mg

Inactive Ingredients

Ingredient Name Strength
ALLANTOIN
CARBOMER 934
GLYCERIN
hydroxyethyl cellulose (4000 mpa.s at 1%)
SODIUM HYDROXIDE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42891-4148-1 5.5 in 1 TUBE
2 NDC:42891-4148-0 6 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part333A 2012-03-28


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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