Sedralex^® (Cream) Instructions for Use

Marketing Authorization Holder

Servier, JSC (Russia)

Manufactured By

Servier Healthcare (France)

Manufactured By

Strand Cosmetics Europe (France)

Dosage Form

Sedralex®

Toning foot cream: tube 150 ml

Dosage Form, Packaging, and Composition

Toning foot cream .

Composition water, ethanol denatured, glycerolum (glycerin), dimethicone, polyacrylamide, phenyl trimethicone, C13-14 isoparaffin, menthol, perfume composition (Fragrance), squalane, propanediol, decyl olivate, extract of roots of chicory ordinary (Cichorium Intybus (Chicorice)), bis-PEG/PPG-20/5 PEG/PPG-20/5 dimethicone, methoxy PEG/PPG-25/4 dimethicone, copolymer of hydroxyethyl acrylate/sodium acryloyldimethyl taurate, hydroxyethyl urea, triglycerides of caprylic/capric acid, laureth-7, diphenyl dimethicone, tocopheryl acetate, extract of fruits of citron Corsican (Citrus Medica Vulgaris), tetrasodium glutamate diacetate, squalene, citric acid, oil soybean (soybeans), polysorbate 60, sorbitan isostearate, phenoxyethanol, urea, biosaccharide gum-1, ammonium lactate, gluconolactone, gum of caesalpinia spinosa, ethanolamine, sodium benzoate, sodium hydroxide, tocopherol, CI 19140 (Yellow 5), CI 42090 (Blue 1), pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, calcium gluconate, alpha-isomethyl ionone, benzyl salicylate, citral, geraniol, hexyl cinnamal, limonene, linalool.

150 ml – tubes plastic (1) – packs cardboard.

Therapeutic Category

Cosmetic products for care of skin of feet

Indications

• Sedralex^® cream is indicated for daily care and toning of the skin of the feet.
• It is formulated to provide a refreshing and light sensation, helping to reduce feelings of tiredness and heaviness in the feet.
• The cream aids in maintaining skin hydration and elasticity, contributing to overall foot comfort, especially after prolonged standing or walking.
• It is suitable for use as part of a regular foot hygiene routine to support the general health and appearance of the skin on the feet.

Contraindications

• Hypersensitivity to any component of the formulation is a strict contraindication. The product contains a complex mixture of active and inactive ingredients, including various extracts, perfumes, and preservatives, which may cause allergic reactions in susceptible individuals.
• Do not use on broken, damaged, wounded, or inflamed skin, including areas with cuts, abrasions, sunburns, or active dermatological conditions such as eczema or psoriasis, as this may lead to increased systemic absorption and potential irritation.
• Avoid application on areas of skin that have recently undergone surgical procedures or other medical treatments unless specifically directed by a healthcare professional.
• Use is contraindicated in individuals with a known history of contact dermatitis triggered by any of the listed ingredients, such as fragrances (e.g., limonene, linalool), preservatives, or botanical extracts.

Dosage Regimen

For external use only. Apply a sufficient amount of Sedralex^® cream to cover the entire foot, focusing on the sole, heel, and areas prone to dryness or discomfort.

Gently massage the cream into the skin until fully absorbed. Use once or twice daily, or as needed to achieve the desired refreshing and toning effect. The frequency of application can be adjusted based on individual needs and the level of foot fatigue experienced.

For optimal results, it is recommended to use the cream on clean, dry skin. Hands should be washed thoroughly before and after application to maintain hygiene and prevent accidental transfer to sensitive areas like the eyes or mucous membranes.

Adverse Reactions

Like all topical products, Sedralex^® cream has the potential to cause adverse reactions, although not everybody gets them. The most commonly reported reactions are localized and mild in nature.

These may include transient skin irritation, redness (erythema), itching (pruritus), a burning sensation, or dryness at the site of application. Such reactions are typically self-limiting and often resolve upon discontinuation of the product.

In rare instances, allergic contact dermatitis may occur. This can manifest as more pronounced redness, swelling, blistering, or severe itching. If any signs of a severe allergic reaction appear, such as widespread rash, dizziness, or difficulty breathing, discontinue use immediately and seek prompt medical attention.

The presence of fragrance components and botanical extracts increases the potential for sensitization, particularly in individuals with a history of atopy or sensitive skin. It is important to monitor the skin’s response, especially during initial use.

Drug Interactions

Formal studies of drug interactions for this cosmetic product have not been conducted. However, as a general precaution, patients using other topical medicinal products on their feet (e.g., antifungals, corticosteroids, keratolytics) should consult a doctor or pharmacist before using Sedralex^® cream.

Concurrent application of multiple products on the same skin area could potentially alter the absorption, efficacy, or irritation profile of either product. It is advisable to maintain a time interval between the application of different topical agents.

There is a theoretical risk that the components of the cream could interact with the materials of occlusive dressings or footwear, potentially increasing penetration and the risk of adverse effects. Avoid covering the treated area with airtight bandages or plastic wraps unless medically advised.

Overdose

Overdose from the topical application of Sedralex^® cream is unlikely due to its intended external use and the low systemic absorption of its components. Accidental ingestion of the product constitutes an overdose and requires immediate medical management.

Symptoms of ingestion may include gastrointestinal irritation, nausea, vomiting, and abdominal pain. Due to the ethanol content, ingestion of large quantities could potentially lead to signs of alcohol intoxication, especially in children.

In case of accidental ingestion, contact a Poison Control Center or a physician immediately. Do not induce vomiting unless directed by medical personnel. If the product comes into contact with the eyes, rinse thoroughly with copious amounts of water for several minutes and seek medical advice if irritation persists.

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.