Label: GUARDIAN VAGINAL- benzalkonium chloride douche

  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 2, 2019

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  • Active ingredient

    Benzalkonium Chloride 0.1%

  • Purpose


  • Uses:

    • for vaginal cleansing. Kills germs.
  • 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.

    • 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

  • 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 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

  • 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

    benzalkonium chloride douche
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68915-280
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68915-280-021 in 1 BOX05/23/2011
    1NDC:68915-280-015.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    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)
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(68915-280)