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.

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Active ingredient                          Purpose

Benzalkonium Chloride  0.1%       antimicrobial


Uses: for vaginal cleaning. Kills germs.


Keep out of reach of children

Stop use and ask a doctor if: rash and irritation and redness develops.

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


Directions:

Insert the gel into the vagina when cleansing is desired, one unit (5.5mL) at a 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 discard in a waste container.
Do not use this product if the package seal is broken.
Children under 12 years of age: ask doctor.

Inactive ingredients

Carbomer, glycerin, hydroxypropylmethylcellulose, methylparaben, sodium hydroxide, water





image of back label

Guardian Gel

Vaginal Douche with Benzalkonium Chloride


0.18 fl oz.  5.5 ml

image of front label


GUARDIAN  VAGINAL
benzalkonium chloride douche
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68915-280
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 934 
GLYCERIN 
HYPROMELLOSES 
METHYLPARABEN 
SODIUM HYDROXIDE 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:68915-280-021 BOTTLE ( BOTTLE) in 1 BOXcontains a BOTTLE (68915-280-01)
1NDC:68915-280-015.5 mL in 1 BOTTLEThis package is contained within the BOX (68915-280-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/23/2011

Labeler - Eastern Century Pharmaceuticals (966499373)
Registrant - Gar Laboratories (074933615)
Establishment
NameAddressID/FEIOperations
Gar Laboratories074933615manufacture

Revised: 06/2011 Eastern Century Pharmaceuticals