FLUGENIL® VAGINAL GEL

Vaginal Moisturizing, Soothing & Mucosal-Care Gel

30 mL Tube with 5 Disposable Vaginal Applicators

Medical Device – CE Marked

Medical Description

Flugenil® Vaginal Gel is a non-hormonal vaginal gel formulated to provide moisturizing, soothing and protective care to the vaginal mucosa. It is intended for women experiencing vaginal dryness and associated discomfort, including irritation, itching, burning and discomfort during sexual intercourse (dyspareunia).

Its formulation combines hyaluronic acid with botanical and supportive ingredients designed to help maintain vaginal moisture, improve mucosal comfort and support the physiological condition of the vaginal tissues.

Hyaluronic acid is a hydrophilic molecule capable of retaining water and is widely used in vaginal moisturizers. Clinical evidence indicates that intravaginal hyaluronic-acid preparations can improve symptoms associated with vaginal dryness, including dryness, irritation, itching, burning and dyspareunia.

Key Components & Their Role

• Hyaluronic Acid: Helps retain water and maintain hydration of the vaginal mucosa. Clinical studies support its use as a non-hormonal vaginal moisturizer for vaginal dryness and related discomfort.
• Soybean Extract, standardized in isoflavones and genistin: Provides naturally occurring soybean-derived isoflavones within the formulation.
• Mallow Extract: Traditionally used in topical preparations for its soothing and emollient properties.
• Boric Acid: Included as part of the product formulation and may contribute to maintenance of the vaginal environment. It should not be interpreted as making the product an antifungal or antibacterial treatment.
• Calendula Distilled Water: Provides botanical support within the formulation.
• Melaleuca / Tea Tree Component (Terpinen-4-ol): Included as a botanical component of the formulation.
• Aloe Vera Gel: Provides moisturizing and soothing support for mucosal and skin comfort.

Benefits

Flugenil® Vaginal Gel may be used as supportive vaginal care for:

• Vaginal dryness and reduced vaginal moisture
• Vaginal irritation and discomfort
• Itching and burning associated with vaginal dryness or mucosal irritation
• Discomfort associated with sexual intercourse (dyspareunia)
• Supportive hydration and conditioning of the vaginal mucosa
• Maintenance of mucosal softness and comfort

Vaginal moisturizers and lubricants are recognized non-hormonal options for relieving vaginal dryness and painful intercourse. ACOG specifically includes hyaluronic acid among non-hormonal topical options for vulvovaginal symptoms.

Hyaluronic Acid & Vaginal Health

Evidence from clinical studies and systematic reviews suggests that vaginal hyaluronic acid can improve vaginal dryness and associated symptoms. A randomized controlled trial found significant improvement in vaginal dryness with hyaluronic-acid vaginal gel, while a systematic review concluded that hyaluronic acid may be an effective non-hormonal option for vulvovaginal dryness and dyspareunia.

More recent evidence also supports the use of hyaluronic-acid vaginal preparations for vulvovaginal discomfort, although formulations, dosing schedules and clinical populations vary between studies.

Important Note Regarding Vaginal Infections

Flugenil® may provide supportive symptomatic care and mucosal moisturizing, but vaginal symptoms such as itching, burning, abnormal discharge or odor can have different causes.

Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) require appropriate clinical assessment and, when confirmed, specific treatment. CDC guidance identifies vaginal pH >4.5 as commonly associated with BV, whereas uncomplicated candidiasis is generally associated with a vaginal pH below 4.5.

Therefore, Flugenil® should not be considered a substitute for antifungal or antibacterial treatment when an active vaginal infection has been diagnosed.

Composition

Main Components:

• Hyaluronic Acid
• Soybean Extract — standardized to 40% isoflavones and 25% genistin
• Glycolic Extract of Mallow
• Boric Acid
• Distilled Water of Calendula
• Melaleuca / Terpinen-4-ol
• Aloe Vera Gel
• Purified/Distilled Water

Recommended Use

The manufacturer's recommended use is:

One vaginal application once daily, using a new disposable applicator for each application.

Treatment may be continued according to individual need and/or medical advice.

How to Use

1. Remove the cap from the tube and attach one disposable vaginal applicator securely to the tube.
2. Gently squeeze the tube to fill the applicator with the required amount of gel.
3. Remove the applicator from the tube.
4. Gently insert the applicator into the vagina.
5. Push the plunger to release the gel.
6. Remove and discard the applicator after use according to the manufacturer's instructions.
7. Use a new applicator for every application.

Warnings & Precautions

• For vaginal use only.
• Do not swallow.
• Do not use if you are known to be allergic or hypersensitive to any of the ingredients.
• Discontinue use and seek medical advice if significant irritation, burning, swelling, rash or other hypersensitivity symptoms occur.
• Do not use after the stated expiration date.
• Do not use if the package or tube is damaged or its integrity is compromised.
• Keep the container tightly closed when not in use.
• Store according to the manufacturer's recommended storage conditions and protect from excessive heat and direct light.
• Keep out of the reach of children.
• If vaginal symptoms are persistent, recurrent, severe, or accompanied by unusual discharge, unpleasant odor, bleeding, pelvic pain or fever, medical evaluation is recommended.
• Women with persistent vaginal symptoms should be assessed for infectious and non-infectious causes rather than relying solely on symptomatic treatment.

Pregnancy & Breastfeeding

If pregnant, trying to conceive or breastfeeding, consult a physician or qualified healthcare professional before use, particularly if symptoms are new, persistent or associated with abnormal discharge, bleeding or pelvic pain.

Storage

Store in a cool, dry place according to the manufacturer's instructions. Protect from excessive heat and direct light. Keep tightly closed and out of reach of children.

Clinical Perspective

Flugenil® is best characterized as a non-hormonal vaginal moisturizing and soothing product intended to improve vaginal hydration and comfort. Evidence supporting hyaluronic-acid vaginal preparations is particularly relevant to vaginal dryness and associated discomfort, including dyspareunia.

Patient Disclaimer:

This information is provided for general educational purposes and does not replace professional medical advice, diagnosis or treatment. Flugenil® is intended for vaginal moisturizing and supportive care and should not be used as a substitute for appropriate medical treatment of bacterial vaginosis, candidiasis, sexually transmitted infections or other vaginal disorders. If symptoms are persistent, recurrent, severe, or associated with abnormal discharge, odor, bleeding, pelvic pain or fever, consult a physician or gynecologist for appropriate evaluation and treatment.

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