AVVA- benzalkonium chloride gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

AVVA International LLC

Administration route:

VAGINAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Antimicrobial 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

AVVA- BENZALKONIUM CHLORIDE GEL
AVVA INTERNATIONAL LLC
_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 FACTS
ACTIVE INGREDIENTS
Benzalkonium Chloride 0.1%
PURPOSE
Antimicrobial
KEEP OUT OF REACH OF CHILDREN if product is swallowed, get medical
help or contact a
poison control center right away
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
DO NOT USE if the package seal is broken
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
DO NOT USE more often than twice weekly unless directed by physician
INACTIVE INGREDIENTS:
allantoin, carbomer, glycerin, hydroxyethylcellulose, sodium
hydroxide, water
AVVA
benzalkonium chloride gel
PRODUCT 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)
BENZ ALKONIUM
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)
HY