Skin-cap

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SKIN-CAP (SKIN-CAP)

Composition:

Active substance: pyrithione zinc;

1 ml of shampoo contains 10 mg of zinc pyrithione;

Excipients: sodium lauryl sulfate copolymer, coco-amido-N amide, glycol stearate, fatty acid alkyldimethylammonium betaine, sodium lauryl sulfate, dimethicone, polypropylene glycol-polyethylene glycol copolymer 55-propylene glycol oleate, menthol, sodium chloride, disodium edetate (Trilon B), purified water.

Pharmaceutical form. Shampoo.

Main physicochemical characteristics: white suspension with a characteristic odor.

Pharmacotherapeutic group.
Dermatological agents. ATC code: D11AX12.

Pharmacological Properties

Pharmacodynamics

The medicinal product has high antibacterial activity against a range of pathogenic microorganisms such as streptococci, staphylococci, Pseudomonas aeruginosa, Escherichia coli, and Proteus. The antifungal activity of the preparation is particularly pronounced against Pityrosporum ovale and Pityrosporum orbiculare, which cause inflammation and excessive desquamation in dandruff, seborrhea, psoriasis, and other skin disorders. The preparation acts against microorganisms located both on the surface and in the deeper layers of the epidermis.

The special formulation of the shampoo, containing surfactants, enhances the antibacterial and antifungal effects of pyrithione zinc, counteracts the normal saprophytic flora in the stratum corneum of the scalp, and helps relieve burning and itching. Activated pyrithione zinc contained in the shampoo inhibits the pathological proliferation of cells in the superficial skin layers and eliminates excessive desquamation in psoriasis, seborrhea, and dandruff.

At therapeutic concentrations, the preparation does not inhibit normally functioning cells.

Pharmacokinetics

When applied topically, pyrithione zinc is deposited in the superficial (epidermal) layers of the skin. Systemic absorption occurs slowly and is detectable in the blood only in trace amounts.

Clinical characteristics.

Indications.

Treatment of psoriasis, scalp dermatitis, itching, dandruff, and dry or oily seborrhea.

Contraindications.

Hypersensitivity to any component of the product.

Interaction with other medicinal products and other forms of interaction.

Skin-Cap should not be used concurrently with products containing glucocorticosteroids.

Instructions for use.

Do not allow the shampoo to enter the eyes. During remission, the shampoo may be used for hair washing 1–2 times a week to prevent relapses. If the frequency of shampoo use increases, skin dryness may occur.

Use during pregnancy or breastfeeding

During pregnancy or breastfeeding, the medicinal product should be used only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery

Has no effect.

Method of Administration and Dosage

Shake the bottle several times before use. Wet the hair. Apply a small amount of Skin-Cap shampoo to the hair. Rinse the shampoo off and apply again, then leave it on the skin surface for 5 minutes. Afterwards, rinse the hair thoroughly with plenty of water. Use at least 2–3 times per week for 2 weeks. If necessary, repeat the treatment course.

Children.

Suitable for use in children aged 1 year and older.

Overdose.

Increased frequency of shampoo application may lead to skin dryness. During this period, it is recommended to reduce or discontinue the use of Skin-Cap. Excessive use may intensify the manifestations of adverse effects.

Side effects.

Allergic reactions are possible, including redness, itching, and skin rashes; skin dryness may also occur (see section "Special precautions").

Shelf life. 5 years.

Storage conditions.

Store at a temperature between 4 and 20 °C in a dark place.

Keep out of reach of children.

Packaging.

75 ml or 150 ml of shampoo in a plastic bottle, in a cardboard package.

Availability. Over-the-counter (without prescription).

Manufacturer. B. BRAUN MEDICAL S.A.

Manufacturer's address.

Ronda de Los Olivos, parcel 11, Industrial Area Los Olivos, city of Jaén, 23009 (Jaén), Spain.