GUARDIAN VAGINAL- benzalkonium chloride douche 
Eastern Century Pharmaceuticals

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.

----------

Eastern Century - Guardian Gel Vaginal Douche

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

antimicrobial

Uses:

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.

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.

Inactive ingredients:

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

Storage:

Store at room temperature in a cool, dry place.

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.

Expiration Date:

Two years after printed date of manufacture.

Precautions:

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

Distributed by:

Eastern Century Pharmaceuticals, US (ECP)
2345 Oakwood Dr., Prescott, AZ 86305 USA
Made in the USA

Front Label

Guardian Gel

Vaginal Douche Gel with Benzalkonium Chloride


0.18 fl oz. 5.5 ml

Image of Front Label

Back Label

Image of BackLabel

GUARDIAN  VAGINAL
benzalkonium chloride douche
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68915-280
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
GLYCERIN 
HYPROMELLOSES 
METHYLPARABEN 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68915-280-021 in 1 BOX
1NDC:68915-280-015.5 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/23/2011
Labeler - Eastern Century Pharmaceuticals (966499373)
Registrant - Eastern Century Pharmaceuticals (966499373)
Establishment
NameAddressID/FEIBusiness Operations
Lifetech Resources, LLC622559110manufacture(68915-280)

Revised: 12/2014
Document Id: 5e976930-5765-48e6-a8c5-92a18e931e7b
Set id: 1605ba44-02b7-4c72-9fec-89a5aa962b44
Version: 7
Effective Time: 20141208
 
Eastern Century Pharmaceuticals