AVVA  - benzalkonium chloride gel 
AVVA International LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients                           
Benzalkonium Chloride  0.1%    

Purpose
Antimicrobial

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

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 if the package seal is broken

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

Carton Image


AVVA 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42891-4148
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
CARBOMER 934 
GLYCERIN 
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) 
SODIUM HYDROXIDE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:42891-4148-01 TUBE ( TUBE) in 1 BOXcontains a TUBE (42891-4148-1)
1NDC:42891-4148-15.5 mL in 1 TUBEThis package is contained within the BOX (42891-4148-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/28/2012

Labeler - AVVA International LLC (020023853)
Establishment
NameAddressID/FEIOperations
AVVA International LLC020023853label

Revised: 03/2012 AVVA International LLC