AVVA VAGINAL- benzalkonium chloride douche 
Eastern Century Pharmaceuticals

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.

----------

Avva Vaginal Douche Gel

Active ingredients                             Purpose

Benzalkonium Chloride  0.1%          Antimicrobial


Uses: for vaginal cleansing. Kills germs.

Keep out of reach of children

Stop use and ask doctor if: Rash or irritation and redness develops.

Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. 

Do not douche to prevent pregnancy

During pregnancy

If you have symptoms of pelvic inflammatory disease (PID) or sexually transmitted disease (STD)

To self treat or prevent a STD or PID

After exposure to STD stop using this product and consult a doctor if douching results in pain, soreness, swelling, redness, itching excessive dryness or irritation, or symptoms continue after 7 days. These may indicate a serious condition.


If swallowed, get medical help or contact a poison control center right away.

External use only

Do not use in eyes.

Directions

Insert the gel into the vagina when cleansing is desired, one unit (5.5 ml) each time.

Please read the following instructions carefully before use.

1. Take off any plastic around the tube.

2. Remove the small plastic tip from the top of the applicator.

3. Gently insert the small end of the applicator deep into the vagina. While in this position, squeeze the contents of the applicator to release the gel. Remove the applicator and discard it in a waste container.

Do not use this product if the package seal is broken

Children under 12 years of age: ask doctor.

Inactive Ingredients

Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, sodium hydroxide, water



image of back of box


Avva
Vaginal Douche Gel with Benzalkonium Chloride

0.18 fl oz  5.5 ml



Image of front label
AVVA  VAGINAL
benzalkonium chloride douche
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68915-256
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 (UNII: Z135WT9208)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68915-256-021 in 1 BOX
1NDC:68915-256-015.5 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2011
Labeler - Eastern Century Pharmaceuticals (966499373)
Registrant - GAR Laboratories (074933615)
Establishment
NameAddressID/FEIBusiness Operations
GAR Laboratories074933615manufacture

Revised: 6/2011
Document Id: 16b04391-8d87-4796-9323-a0a960eb592a
Set id: 9a46a21f-3e62-4e90-84a2-00e99f3d9e9c
Version: 5
Effective Time: 20110609
 
Eastern Century Pharmaceuticals