Eastern Century - Guardian Gel Vaginal Douche

Eastern Century - Guardian Gel Vaginal Douche
SPL v11
SPL
SPL Set ID 1605ba44-02b7-4c72-9fec-89a5aa962b44
Route
VAGINAL
Published
Effective Date 2015-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (1 mg)
Inactive Ingredients
Carbomer 934 Glycerin Hypromelloses Methylparaben Sodium Hydroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-05-23

Description

Benzalkonium Chloride 0.1%

Purpose

antimicrobial


Medication Information

Purpose

antimicrobial

Description

Benzalkonium Chloride 0.1%

Uses:
  • for vaginal cleansing. Kills germs.
Section 50565-1

Keep out of reach of children.

Storage:

Store at room temperature in a cool, dry place.

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.

Back Label

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.
Front Label

Guardian Gel

Vaginal Douche Gel with Benzalkonium Chloride



0.18 fl oz. 5.5 ml

Precautions:

Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. Guardian Gel TM is an effective douche when used according to the directions.

Distributed By:

Eastern Century Pharmaceuticals, US (ECP)

One Pierce Place, #475W, Itasca, IL  60143 USA

Made in the USA

Expiration Date:

Two years after printed date of manufacture.

Active Ingredient

Benzalkonium Chloride 0.1%

Discontinue Use If

any burning, itching, or irritation of the vagina occur during use.

Other Information:

An association has been reported between douching and pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. It is not currently known whether douching is casually related to these conditions, but women should be aware of this association. See a doctor right away if you have symptoms of PID or STD.

Inactive Ingredients:

Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, Sodium Hydroxide, Water

Stop Use and Ask A Doctor If:

Rash and irritation and redness develops.


Structured Label Content

Uses:
  • for vaginal cleansing. Kills germs.
Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

antimicrobial

Storage:

Store at room temperature in a cool, dry place.

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.

Back Label

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.
Front Label

Guardian Gel

Vaginal Douche Gel with Benzalkonium Chloride



0.18 fl oz. 5.5 ml

Precautions:

Discontinue use if any burning, itching, or irritation of the vagina occurs during use. Wash and douche with water. Guardian Gel TM is an effective douche when used according to the directions.

Distributed By: (Distributed by:)

Eastern Century Pharmaceuticals, US (ECP)

One Pierce Place, #475W, Itasca, IL  60143 USA

Made in the USA

Expiration Date:

Two years after printed date of manufacture.

Active Ingredient (Active ingredient)

Benzalkonium Chloride 0.1%

Discontinue Use If (Discontinue use if)

any burning, itching, or irritation of the vagina occur during use.

Other Information:

An association has been reported between douching and pelvic inflammatory disease (PID), ectopic pregnancy, and infertility. It is not currently known whether douching is casually related to these conditions, but women should be aware of this association. See a doctor right away if you have symptoms of PID or STD.

Inactive Ingredients: (Inactive ingredients:)

Carbomer, Glycerin, Hydroxypropylmethylcellulose, Methylparaben, Sodium Hydroxide, Water

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

Rash and irritation and redness develops.


Advanced Ingredient Data


Raw Label Data

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