Salicylic acid

INSTRUCTION
for medical use of medicinal product

SALICYLIC ACID
(SALICYLIC ACID)

Composition:

active ingredient: salicylic acid;

100 ml of solution contains 1 g of salicylic acid;

excipient: ethanol 70%.

Pharmaceutical form. Alcoholic solution for external use.

Main physicochemical properties: clear, colorless liquid with an alcohol odor.

Pharmacotherapeutic group. Dermatological agents.

ATC code D01A E12.

Pharmacological properties

An antiseptic agent. Exerts antimicrobial, irritant, and counterirritant effects when applied locally.

Clinical characteristics

Indications. Used for infectious skin disorders: common acne, pyoderma.

Contraindications. Hypersensitivity to the medicinal product.

Special precautions. Avoid contact with eyes; do not apply to mucous membranes.

Do not violate the instructions for use of the medicinal product — this may harm health.

Interaction with other medicinal products and other forms of interactions

Topical use of salicylic acid should not be combined with oral administration of drugs containing acetylsalicylic acid and other nonsteroidal anti-inflammatory agents. Do not use concurrently with benzoyl peroxide and topical retinoids.

Salicylic acid may increase skin permeability to other topical medicinal products, thereby enhancing their systemic absorption. In addition, salicylic acid may potentiate the adverse effects of methotrexate and the hypoglycemic effect of oral antidiabetic sulfonylurea derivatives.

If the patient is taking any other medicinal products, it is mandatory to inform the physician.

Special instructions.

Do not apply the medicinal product to large areas of skin.

Use during pregnancy or breastfeeding. During pregnancy and breastfeeding, the use of the medicinal product is permissible only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate when driving or operating machinery. No effect.

Method and dosage of administration

For external use only. Apply by swabbing or rubbing the affected skin areas with a cotton swab soaked in the solution, 2–3 times daily. The duration of treatment is determined by the physician depending on the course and severity of the disease.

Children. Not recommended for children under 12 years of age.

Overdose

When large doses are used, keratolytic effects and allergic reactions may intensify. In such cases, the product should be washed off with water and medical advice should be sought. Symptomatic treatment is recommended.

Adverse reactions

Possible skin reactions: dryness, peeling, irritation, contact dermatitis, allergic manifestations (urticaria, pruritus), which may require discontinuation of the medicinal product.

With prolonged use, systemic absorption of the product may occur, leading to salicylate-like adverse effects: tinnitus, dizziness, epigastric pain, nausea, vomiting, acidosis, rapid breathing.

If any adverse events occur, consult a physician immediately!

Reporting adverse reactions after medicinal product registration is highly important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

The medicinal product must not be used after the expiry date stated on the packaging!

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 40 ml in a glass bottle.

Prescription status. Over-the-counter.

Manufacturer. Limited Liability Company "UKRSPECFARM".

Manufacturer's address and place of business

Ukraine, 69092, Zaporizhzhia region, Zaporizhzhia, Tsehelna St., 249.