Phlebodia^® cream gel (Gel Cream) Instructions for Use

Marketing Authorization Holder

Innotech LLC (Russia)

Manufactured By

Dzintars, JSC (Latvia)

On Behalf Of

INNOTEK, LLC (Russia)

Dosage Form

Phlebodia® cream-gel

Foot cream-gel: tube 50 ml

Dosage Form, Packaging, and Composition

Foot cream-gel in the form of a homogeneous mass of dark pink color, without foreign impurities.

Composition natural bioflavonoid diosmin, menthol.

50 ml – tubes (1) – carton packs.

Therapeutic Category

Cosmetic products for foot skin care

Indications

• For the temporary relief of discomfort and heaviness in the legs associated with mild venous insufficiency.
• To provide a cooling and refreshing sensation to the skin of the feet and lower legs.
• For use as part of a daily skincare routine for individuals who experience fatigue and mild swelling in the lower extremities.

This product is intended for cosmetic and symptomatic relief and is not a treatment for underlying venous disease. For persistent or severe symptoms, consultation with a healthcare professional is mandatory.

Dosage Regimen

For external use only. Apply a sufficient amount of Phlebodia^® cream-gel to cover the affected area of the feet and lower legs.

Gently massage the cream-gel into the skin using upward, circular motions until fully absorbed. The frequency of application is typically 1 to 3 times per day, or as needed for relief of discomfort.

For best results, it is recommended to use the product consistently as part of your daily foot care regimen. Avoid contact with eyes, mucous membranes, and broken or irritated skin. Wash hands thoroughly after application unless the hands are the treated area.

Contraindications

• Hypersensitivity to diosmin, menthol, or any other component of the formulation.
• Application to broken, damaged, or diseased skin, including wounds, sunburns, or severe dermatitis.
• Use is not recommended in individuals with a known allergy to plants of the Rutaceae family (e.g., citrus fruits) without prior consultation with a physician, as diosmin is a citrus bioflavonoid.

If you experience any signs of an allergic reaction, such as rash, itching, or redness, discontinue use immediately and consult a healthcare provider.

Adverse Reactions

Phlebodia^® cream-gel is generally well-tolerated. However, as with any topical product, local skin reactions may occur in some individuals.

These reactions are typically mild and transient and may include redness (erythema), itching (pruritus), a burning sensation, or mild skin irritation at the site of application.

In rare cases, allergic contact dermatitis may develop. If any adverse reaction is severe or persists, discontinue use of the product and seek medical advice. Reporting suspected adverse reactions is important for continuous safety monitoring.

Drug Interactions

No specific drug interactions with topical Phlebodia^® cream-gel have been reported. Since systemic absorption of the active ingredients after topical application is expected to be minimal, the risk of clinically significant interactions with concurrently administered oral or other systemic medications is considered low.

However, as a general precaution, you should inform your doctor or pharmacist about all the products you are using, including prescription, over-the-counter medicines, and other herbal or cosmetic products.

Avoid concurrent use with other topical preparations (e.g., creams, ointments, lotions) on the same area of skin unless directed by a healthcare professional, as this may alter the effects of either product or increase the risk of skin reactions.

Overdose

Overdose from topical application of Phlebodia^® cream-gel is unlikely. Excessive application may lead to an increased incidence of the local adverse reactions described above, such as pronounced skin irritation or a strong cooling sensation.

If the product is accidentally ingested orally, seek immediate medical attention or contact a Poison Control Center. Symptoms of oral ingestion may include gastrointestinal discomfort. Do not induce vomiting unless instructed by medical personnel.

In case of topical overdose, thoroughly wash the affected area with mild soap and water to remove the product. If irritation persists, consult a healthcare professional.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.