Drugplain

Guardian Vaginal 1 mg/mL

Benzalkonium Chloride · DOUCHE · Eastern Century Pharmaceuticals

No Recall History
Plain English

Guardian Vaginal is an over-the-counter vaginal douche containing benzalkonium chloride that is used for vaginal cleansing. This product is applied directly into the vagina and works as an antimicrobial agent.

Key Facts

Brand Name
Guardian Vaginal
Generic Name
Benzalkonium Chloride
NDC Code (Product)
68915-280
Manufacturer
Eastern Century Pharmaceuticals
Strength
1 mg/mL
Dosage Form
DOUCHE
Route
VAGINAL
Marketing Status
Application #
M003
Marketing Start
05/23/2011

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective126 reports
drug hypersensitivity118 reports
condition aggravated114 reports
therapy non-responder113 reports
arthralgia112 reports
musculoskeletal stiffness111 reports
pain in extremity111 reports
infection110 reports
hepatotoxicity108 reports
musculoskeletal pain108 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses: for vaginal cleansing. Kills germs.

Dosage & Administration

Directions: Insert the gel into the vagina when cleansing is desired, one unit (5.5ml) 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 entire 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.

Warnings

Warnings: Wash and douche with water. Do not Douche to prevent pregnancy. During pregnancy. If you have symptoms of pelvic inflammatory disease (PID) or a sexually transmitted disease (STD). To self-treat or prevent a STD or PID. After exposure to a STD Stop using this product 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 serious condition. If swallowed, get medical help or contact a Poison Control Center right away. External use only. Do not use in eyes. Stop use and ask a doctor if: Rash and irritation and redness develops. Discontinue use if any burning, itching, or irritation of the vagina occur during use. Keep out of reach of children.

Frequently Asked Questions

What is Guardian Vaginal used for?

Guardian Vaginal is an over-the-counter vaginal douche containing benzalkonium chloride that is used for vaginal cleansing. This product is applied directly into the vagina and works as an antimicrobial agent.

Is Guardian Vaginal a controlled substance?

Guardian Vaginal is not classified as a controlled substance by the DEA.

What is the generic name for Guardian Vaginal?

The generic name for Guardian Vaginal is Benzalkonium Chloride. There are 12 other brand versions of Benzalkonium Chloride.

What is the NDC code for Guardian Vaginal 1 mg/mL?

The NDC (National Drug Code) for Guardian Vaginal 1 mg/mL is 68915-280, listed by Eastern Century Pharmaceuticals.