Label: GUARDIAN VAGINAL- benzalkonium chloride douche

  • NDC Code(s): 68915-280-01, 68915-280-02
  • Packager: Eastern Century Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzalkonium Chloride 0.1%

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  • Purpose

    antimicrobial

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  • Uses:

    • for vaginal cleansing. Kills germs.
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  • 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.

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  • 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.
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  • Inactive ingredients:

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

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  • Storage:

    Store at room temperature in a cool, dry place.

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  • 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.

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  • Expiration Date:

    Two years after printed date of manufacture.

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  • 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.

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  • Distributed by:

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

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  • Front Label

    Guardian Gel

    Vaginal Douche Gel with Benzalkonium Chloride


    0.18 fl oz. 5.5 ml

    image of front label

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  • Back Label
  • INGREDIENTS AND APPEARANCE
    GUARDIAN  VAGINAL
    benzalkonium chloride douche
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68915-280
    Route of Administration VAGINAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOMER 934  
    GLYCERIN  
    HYPROMELLOSES  
    METHYLPARABEN  
    SODIUM HYDROXIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68915-280-02 1 in 1 BOX
    1 NDC:68915-280-01 5.5 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 05/23/2011
    Labeler - Eastern Century Pharmaceuticals (966499373)
    Registrant - Eastern Century Pharmaceuticals (966499373)
    Establishment
    Name Address ID/FEI Business Operations
    Lifetech Resources, LLC 622559110 manufacture(68915-280)
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