Label: AVVA- benzalkonium chloride gel
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Contains inactivated NDC Code(s)
NDC Code(s): 42891-4148-0, 42891-4148-1 - Packager: AVVA International LLC
- 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 January 14, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
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 - GENERAL PRECAUTIONS
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WARNINGS
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 - DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVVA
benzalkonium chloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42891-4148 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 100 mg in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:42891-4148-0 6 in 1 BOX 03/28/2012 1 NDC:42891-4148-1 5.5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/28/2012 Labeler - AVVA International LLC (020023853)
