AVVA VAGINAL- benzalkonium chloride douche

AVVA by

Drug Labeling and Warnings

AVVA by is a Otc medication manufactured, distributed, or labeled by Eastern Century Pharmaceuticals, GAR Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Avva
Vaginal Douche Gel with Benzalkonium Chloride

0.18 fl oz  5.5 ml

INGREDIENTS AND APPEARANCE

AVVA  VAGINAL
benzalkonium chloride douche

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68915-256
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 934 (UNII: Z135WT9208)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68915-256-02	1 in 1 BOX
1	NDC: 68915-256-01	5.5 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/20/2011

Labeler - Eastern Century Pharmaceuticals (966499373)

Registrant - GAR Laboratories (074933615)

Establishment
Name	Address	ID/FEI	Business Operations
GAR Laboratories		074933615	manufacture