Skin-cap

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

Composition:

Active substance: pyrithione zinc;

1 g of cream contains pyrithione zinc 2 mg;

Excipients: polyglyceryl-3 distearate, methyl glucose, stearyl alcohol, glyceryl stearate, octyl octanoate, isopropyl palmitate, sucrose cocoate, cyclomethicone, glycerin, methyl gluceth-20, methylparaben (E 218), butylated hydroxytoluene, CI 10680, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white cream 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 drug is particularly pronounced against Pityrosporum ovale and Pityrosporum orbiculare, which cause inflammation and excessive desquamation in psoriasis and other skin disorders. The drug acts against microorganisms located both on the surface and in the deeper layers of the epidermis.

The special formulation of the cream has hydrating properties, enhances the antibacterial and antifungal effects of pyrithione zinc, and helps relieve burning and itching. Activated pyrithione zinc contained in the cream suppresses the pathological growth of skin surface cells that are in a state of pathological hyperproliferation, eliminating excessive desquamation in psoriasis and other skin diseases. The drug acts against microorganisms located both on the surface and in the deeper layers of the epidermis.

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, atopic dermatitis, and seborrheic eczema in adults and children aged 1 year and older, especially in widespread forms, accompanied by itching, irritation, inflammatory reactions, and skin dryness. The product can be used during remission for maintenance therapy and prevention of relapses, allowing rapid elimination of the manifest phase and acceleration of clinical recovery.

Contraindications.

Hypersensitivity to any component of the product.

Interaction with other medicinal products and other forms of interaction.

Concomitant use with ointments and creams containing glucocorticosteroids is not recommended.

Special precautions for use.

Avoid contact of the cream with the eyes. During remission, apply the cream to affected skin areas at the first signs of disease flare-up. If the frequency of cream application is increased, mild, transient local burning of the skin may occur.

Use during pregnancy or breastfeeding

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

During breastfeeding, do not apply the cream to the nipples.

Ability to influence reaction rate while driving or operating machinery

Has no effect.

Administration and Dosage.

Apply to affected skin twice daily.

For psoriasis, the treatment course lasts 1–1.5 months; for atopic dermatitis – 3–4 weeks; for other conditions, the cream should be used until symptoms completely disappear. In case of residual symptoms (hyperemia, dryness, desquamation, pigmentation), continue using the cream for 1–2 weeks.

Children.

Not recommended for children under 1 year of age.

Overdose.

Not described. Possible intensification of adverse effects manifestations.

Side effects.

Allergic reactions are possible, including redness, itching, skin rash; possible changes at the application site, including a burning sensation at the site of application (see section "Instructions for Use").

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

50 g or 15 g of cream in a polyethylene tube, in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

B. BROWN MEDICAL S.A.

Manufacturer's address.

Ronda de Los Olivos, plot 11, Industrial Estate Los Olivos, city of Jaén, 23009 (Jaén), Spain.