Salicylic-zinc paste

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SALICYLIC-ZINC PASTE

Composition:

Active substances: 1 g of paste contains 0.02 g of salicylic acid, 0.25 g of zinc oxide;

Excipients: potato starch, white soft paraffin.

Pharmaceutical form. Paste.

Main physicochemical properties: homogeneous mass of white color with a yellowish tint.

Pharmacotherapeutic group.

Dermatological agents. Medicinal products with emollient and protective action. Medicinal products containing salicylic acid.

ATC code D02AF.

Pharmacological Properties.

Pharmacodynamics. A combined medicinal product for external use, whose action is determined by the therapeutic properties of its components. Salicylic acid exerts anti-inflammatory, antiseptic, and mild local irritant effects. Zinc exerts weak antimicrobial, astringent, and adsorbing effects, dries the skin, thereby reducing exudation and contributing to the reduction of local inflammatory and irritant manifestations.

Pharmacokinetics. When applied topically, salicylic-zinc paste is practically not absorbed into the systemic circulation and does not produce resorptive effects.

Clinical characteristics.

Indications.

Skin diseases: dermatitis, intertrigo, pyoderma, acne rosacea, acne, eczema, ulcers with predominant exudation.

Contraindications.

Hypersensitivity to the components of the medicinal product. Acute purulent skin diseases and adjacent tissues.

Interaction with other medicinal products and other types of interactions.

When used simultaneously with topical medicinal products, new compounds with unpredictable effects may be formed.

Special precautions for use

Avoid contact of the paste with eyes and wounds. If the paste accidentally gets into the eyes, rinse thoroughly with plenty of running water.

Application of the paste is not recommended on excessively exuding areas of skin or in cases of excessive dryness.

Do not use during acute purulent processes. Do not apply to mucous membranes.

Use during pregnancy or breastfeeding

Use of the medicinal product is not recommended in pregnant or breastfeeding women.

Data on the use of Salicylic-Zinc Paste during pregnancy are lacking or limited.

Salicylic-Zinc Paste should not be used during pregnancy, except for short-term treatment of a small, localized area of skin, such as warts, calluses, including interdigital calluses.

It is unknown whether systemic exposure to Salicylic-Zinc Paste following topical application could be harmful to the embryo/fetus.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiopulmonary and renal toxicity in the fetus; near term, prolonged bleeding may occur in both mother and child, and labor may be prolonged.

Ability to influence reaction rate when driving or operating machinery

No influence.

Method of Administration and Dosage.

Apply externally to adults. Apply the paste as a topical application to affected areas of the skin 1–2 times daily.

The duration of treatment depends on the nature of the disease and is approximately 6 to 20 days.

Children.

The medicinal product is not intended for use in children.

Overdose.

Prolonged application to large areas of skin may intensify allergic reactions.

In such cases, the patient should discontinue use of the medicinal product and consult a physician.

Side effects.

Possible allergic reactions including itching, rash, burning, dryness, peeling of the skin, urticaria, hyperemia. Allergic reactions to the paste components.

Shelf life. 4 years.

Storage conditions.

Store at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

25 g in tubes, in a carton or without a carton.

Availability. Over-the-counter.

Manufacturer/Marketing authorization holder.

LLC "Ternofarm".

Manufacturer's address and place of business activity / Marketing authorization holder's address.

LLC "Ternofarm".

4 Fabrychna Street, Ternopil, 46010, Ukraine.