Radevit^® Active (Ointment) Instructions for Use

Marketing Authorization Holder

Retinoids JSC (Russia)

ATC Code

D10AD (Topical retinoids for acne treatment)

Active Substances

Tocopherol (Ph.Eur. European Pharmacopoeia)

Retinol (Rec.INN WHO registered)

Colecalciferol (Rec.INN WHO registered)

Dosage Form

Radevit® Active

Ointment for external use 10 mg+5 mg+0.05 mg/1 g: tubes 10 g, 15 g, 20 g or 35 g

Dosage Form, Packaging, and Composition

Ointment for external use is homogeneous, from white to light yellow in color.

* (calculated as 100% Retinyl palmitate); composition per 1 g of substance: vitamin A palmitate – 982 mg (1.7 million IU), butylhydroxyanisole – 9 mg, butylhydroxytoluene – 9 mg or vitamin A palmitate – 1.7 million IU, butylhydroxytoluene – 17 mg, sunflower oil – up to 1 g.
** (calculated as 100% Colecalciferol); composition per 1 g of substance: vitamin D₃ – 25 mg (1 million IU), DL-Alpha-Tocopherol Acetate – 2.5 mg, medium-chain triglycerides – 972.5 mg.

Excipients : butylhydroxytoluene – 1 mg, butylhydroxyanisole – 1 mg, emulsifying wax – 80 mg, liquid paraffin (vaseline oil) – 50 mg, glycerol (glycerin) – 100 mg, ethanol (ethyl alcohol 95%) – 100 mg, purified water – up to 1 g.

10 g – aluminum tubes (1) with a cap – cardboard packs.
15 g – aluminum tubes (1) with a cap – cardboard packs.
20 g – aluminum tubes (1) with a cap – cardboard packs.
35 g – aluminum tubes (1) with a cap – cardboard packs.

Clinical-Pharmacological Group

A drug improving trophism and tissue regeneration, for external use

Pharmacotherapeutic Group

Dermatoprotective agent

Pharmacological Action

A combined dermatoprotective agent for topical use. It has anti-inflammatory, emollient, moisturizing, reparative, and antipruritic effects, normalizes keratinization processes, and enhances the protective function of the skin.

Indications

Ichthyosis, ichthyosiform dermatoses (as part of complex therapy); seborrheic dermatitis; cracks, skin erosions; burns; non-infected wounds, ulcers; eczema; atopic dermatitis; diffuse neurodermatitis; allergic contact dermatitis (outside the exacerbation period); psoriasis; dry skin.

Prevention of inflammatory and allergic skin diseases during remission, after discontinuation of treatment with ointments containing corticosteroids; for easily irritated skin, including with increased sensitivity to cosmetics.

ICD codes

Dosage Regimen

Apply a thin layer to the skin in the affected area 2 times a day (in the morning and before bedtime).

In case of severe skin peeling, an occlusive dressing is applied, which stops the access of air to the affected area. Before applying the drug to cracks and other skin defects, they must be pre-treated with antiseptic agents.

The duration of treatment depends on the location and severity of the process and may be several weeks.

Adverse Reactions

Possibleallergic reactions.

Use in acute inflammatory skin diseases may cause increased itching and redness of the skin.

Contraindications

Hypervitaminosis A, hypervitaminosis E, hypervitaminosis D, intake of retinoids,hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

It is not recommended to apply to large areas of skin during pregnancy and breastfeeding.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.