Salicylo-zinc paste

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

Composition:

Active substances: salicylic acid, zinc oxide;

100 g of the paste contains salicylic acid – 2 g, zinc oxide – 25 g;

Excipients: potato starch, white soft paraffin.

Pharmaceutical form. Paste.

Main physico-chemical properties: homogeneous paste of white or white with a slightly noticeable yellowish tint.

Pharmacotherapeutic group. Emollient and protective agents. Salicylic acid preparations. ATC code D02AF.

Pharmacological properties.

Pharmacodynamics.

A combined preparation for topical use. The low concentration of salicylic acid contained in it (2%) exerts anti-inflammatory, antimicrobial, and keratoplastic effects. It suppresses secretion of sebaceous and sweat glands. Zinc oxide exerts weak antimicrobial, astringent, and adsorbing effects, dries the skin, thereby reducing exudation and contributing to a decrease in local manifestations of inflammation and irritation.

Pharmacokinetics.

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

Clinical characteristics.

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

Contraindications. Hypersensitivity to the components of the drug. Acute purulent skin diseases and adjacent tissues.

Special precautions. The paste must not be allowed to enter the eyes. If the paste accidentally gets into the eyes, they should be thoroughly rinsed with a large amount of running water.

The paste is not recommended for application to areas of skin with excessive exudation, as well as in cases of excessive skin dryness.

The use of the paste is not recommended in acute purulent processes. Do not apply to mucous membranes.

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.

Use during pregnancy or breastfeeding. The safety and clinical efficacy of the drug during pregnancy and breastfeeding have not been studied.

Ability to affect reaction speed when driving or operating machinery. The effect of the drug on the ability to drive or operate machinery has not been described.

Method of administration and dosage.

Apply the paste thinly to the affected area 2–3 times daily in adults. The duration of treatment is from 6 to 20 days.

Children. The drug is not intended for use in pediatric patients.

Overdose. Increased manifestations of adverse reactions.

Side effects.

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

Shelf life. 4 years.

Storage conditions. Store in original packaging at a temperature not exceeding 25 °C; do not freeze. Keep out of reach of children.

Packaging. 25 g in containers; 20 g in aluminum tubes, in a carton or without carton; 20 g or 25 g in laminated tubes, in a carton or without carton.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of Marketing Authorization Holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.