Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 0aadfe31-2d94-4bae-9a6b-081c149c374d
Route
VAGINAL
Published
Effective Date 2012-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (100 mg)
Inactive Ingredients
Allantoin Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Glycerin Hydroxyethyl Cellulose (4000 Mpa.s At 1%) Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-03-28
Description

Active ingredients Benzalkonium Chloride  0.1%    

Medication Information

Warnings and Precautions

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

Indications and 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

Dosage and Administration

Do not use more often than twice weekly unless directed by physician

Description

Active ingredients Benzalkonium Chloride  0.1%    

Section 34072-9

Do not use if the package seal is broken

Section 50565-1

Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away

Section 51727-6

Inactive Ingredients:

allantoin, carbomer, glycerin, hydroxyethylcellulose, sodium hydroxide, water

Section 51945-4

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredients

Benzalkonium Chloride  0.1%    



Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Do not use more often than twice weekly unless directed by physician

Warnings and Precautions (34071-1)

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

Section 34072-9 (34072-9)

Do not use if the package seal is broken

Section 50565-1 (50565-1)

Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away

Section 51727-6 (51727-6)

Inactive Ingredients:

allantoin, carbomer, glycerin, hydroxyethylcellulose, sodium hydroxide, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active ingredients

Benzalkonium Chloride  0.1%    



Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:58.245224 · Updated: 2026-03-14T23:00:14.731892