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AVVA vaginal

Dosage form: douche
Ingredients: BENZALKONIUM CHLORIDE 0.1mL in 100mL
Labeler: Eastern Century Pharmaceuticals
NDC Code: 68915-256

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




Avva
Vaginal Douche Gel with Benzalkonium Chloride

0.18 fl oz  5.5 ml



AVVA  VAGINAL
benzalkonium chloride douche
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68915-256
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
GLYCERIN 
HYPROMELLOSES 
METHYLPARABEN 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:68915-256-021 BOTTLE (BOTTLE) 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/FEIOperations
GAR Laboratories074933615manufacture

Revised: 06/2011
 
Eastern Century Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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