Label: AVVA VAGINAL- benzalkonium chloride douche
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Contains inactivated NDC Code(s)
NDC Code(s): 68915-256-01, 68915-256-02 - Packager: Eastern Century Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 9, 2011
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ACTIVE INGREDIENT
Active ingredients Purpose
Benzalkonium Chloride 0.1% Antimicrobial
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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVVA VAGINAL
benzalkonium chloride doucheProduct 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
