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NDC 42891-4148-00 AVVA 100 mg/100mL Details
AVVA 100 mg/100mL
AVVA is a VAGINAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by AVVA International LLC. The primary component is BENZALKONIUM CHLORIDE.
Product Information
NDC | 42891-4148 |
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Product ID | 42891-4148_4bcdae7c-0f1a-494c-91bd-461443032e8a |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | AVVA |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Benzalkonium chloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | GEL |
Route | VAGINAL |
Active Ingredient Strength | 100 |
Active Ingredient Units | mg/100mL |
Substance Name | BENZALKONIUM CHLORIDE |
Labeler Name | AVVA International LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH NOT FINAL |
Application Number | part333A |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 42891-4148-00 (42891414800)
NDC Package Code | 42891-4148-0 |
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Billing NDC | 42891414800 |
Package | 6 TUBE in 1 BOX (42891-4148-0) / 5.5 mL in 1 TUBE (42891-4148-1) |
Marketing Start Date | 2012-03-28 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0aadfe31-2d94-4bae-9a6b-081c149c374d Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
AVVA
benzalkonium chloride gel |
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Labeler - AVVA International LLC (020023853) |