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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Drug Facts

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 AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE100 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42891-4148-06 in 1 BOX03/28/2012
1NDC:42891-4148-15.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/28/2012
Labeler - AVVA International LLC (020023853)

Revised: 1/2022
Document Id: 4bcdae7c-0f1a-494c-91bd-461443032e8a
Set id: 0aadfe31-2d94-4bae-9a6b-081c149c374d
Version: 10
Effective Time: 20220114
 
AVVA International LLC