Bioderma Atoderm Intensive baume (Balm) Instructions for Use

Marketing Authorization Holder

Naos Vostok, LLC (Russia)

Manufactured By

Naos (France)

Contact Information

NAOS VOSTOK LLC (Russia)

Dosage Form

Bioderma Atoderm Intensive baume

Balm: 75 ml or 200 ml tube, 500 ml bottle

Dosage Form, Packaging, and Product Composition

Balm for skin care.

Composition aqua/water/eau, glycerin, paraffinum liquidum/mineral oil/huile minerale, helianthus annuus (sunflower) seed oil, behenyl alcohol, sucrose stearate, canola/canola oil/huile de colza, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pentylene glycol, beta-sitosterol, xylitol, zinc gluconate, acrylates/C10-30 alkyl acrylate crosspolymer, palmitamide mea, 1,2-hexanediol, caprylyl glycol, sodium citrate, mannitol, rhamnose, sodium lauroyl lactylate, sodium hydroxide, polysorbate 60, sorbitan isostearate, tocopherol, phytosphingosine, ceramide NP, ethylhexylglycerin, ceramide AP, cholesterol, carbomer, xanthan gum, fructooligosaccharides, caprylic/capric triglyceride, laminaria ochroleuca extract, citric acid, ceramide EOP. [BI 669].

75 ml – polymer tubes (1) – cardboard boxes.
200 ml – polymer tubes.
500 ml – polymer bottles with a dispenser.

Therapeutic Category

Cosmetic product for the care of dry and atopic skin

Properties

Bioderma Atoderm Intensive Balm helps relieve symptoms accompanying dry, very dry, and atopic skin. It also soothes, moisturizes, and increases resistance to aggressive factors.

The balm soothes dry skin, helping to reduce the sensation of itching and scratching. Bioderma Atoderm Intensive Balm restores the protective skin barrier and the balance of the microbiome. It moisturizes the skin for 24 hours. Helps manage eczema.

Technologies

• The Skin Barrier Therapy^® patent restores the balance of the atopic skin microbiome and prevents irritation.
• The Lipigenium^® technology restores the protective skin barrier by stimulating lipid production.
• The D.A.F.^® patent increases the skin’s resistance to environmental factors and reduces its reactivity.

Scope of Application

Of the Bioderma Atoderm Intensive baume product

• For very dry, irritated, and atopy-prone sensitive skin of the face and body.

Indications

• For the management and care of very dry, rough, and scaly skin on the face and body.
• For the symptomatic relief of skin irritation and itching associated with extreme dryness.
• For the restoration of the skin barrier and improvement of skin hydration in conditions of xerosis.
• For the adjuvant care of skin prone to atopic dermatitis and eczema to help reduce flare-ups.
• For the daily maintenance of sensitive skin requiring intensive moisturization and protection from environmental aggressors.

ICD codes

Dosage Regimen

Apply externally to cleansed skin of the face and body.

Use once or twice daily. Increase frequency of application on areas of very dry or irritated skin as needed.

Apply a sufficient amount to cover the entire treatment area with a thin, uniform layer. Use on infants from birth (excluding premature infants), children, and adults.

This product is suitable for concomitant use with topical corticosteroids; apply the balm first and allow it to absorb fully.

Adverse Reactions

Adverse reactions are uncommon.

In rare cases, transient local reactions such as erythema, itching, or a burning sensation may occur, particularly on severely compromised skin.

Discontinue use immediately if signs of hypersensitivity or any other severe reaction appear. Consult a healthcare professional if irritation persists.

Drug Interactions

No specific pharmacodynamic interactions with other medicinal products are known.

This balm is intended for concomitant use with topical corticosteroid therapy as part of a managed treatment regimen for inflammatory skin conditions.

When used with other topical products, apply this balm first and allow it to be fully absorbed before applying any subsequent medicinal product to avoid potential physical dilution or barrier effects.

Contraindications

• Hypersensitivity to any of the components listed in the composition. Discontinue use immediately if signs of an allergic reaction appear.

• Application to actively infected skin without concurrent appropriate antimicrobial therapy. Treat the underlying infection first.

• Use on premature infants or newborns in a neonatal intensive care setting due to their underdeveloped skin barrier and increased systemic absorption risk.

Overdose

Overdose from topical application is unlikely due to the product’s external use and cosmetic nature.

Excessive application may lead to a greasy feel on the skin or staining of clothing, but is not associated with systemic toxicity.

In case of accidental ingestion, seek medical attention if large quantities are consumed or if adverse symptoms occur. Provide symptomatic and supportive care as there is no specific antidote.

Contraindications

No contraindications have been established.

Special Instructions

For infants 0+ (except for premature infants), children, and adults.

Rich, non-sticky texture. Fragrance-free. High tolerance. Tested under dermatological control.

The product is created based on the principles of ecobiology.

Storage Conditions

Keep out of reach of children at a temperature not lower than 5°C (41°F) and not higher than 25°C (77°F), away from direct sunlight.

Shelf Life

The expiration date is indicated on the packaging.

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.