SALICYLIC ACID ALCOHOLIC SOLUTION

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SALICYLIC ACID ALCOHOLIC SOLUTION

Composition:

Active ingredient: salicylic acid;

100 ml of solution contain 1 g of salicylic acid;

Excipient: ethanol 70%.

Pharmaceutical form. Alcoholic solution for external use.

Main physicochemical properties: clear, colorless liquid with a characteristic alcoholic odor.

Pharmacotherapeutic group.
Dermatological agents. ATC code D01AE12.

Pharmacological properties.

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

Clinical characteristics.

Indications.

Used for infectious skin lesions: common acne, pyoderma.

Contraindications.

Hypersensitivity to the drug.

Safety precautions.

Avoid contact of the drug with eyes; do not apply to mucous membranes.

Do not violate the application instructions, as this may harm your health.

Interaction with other medicinal products and other forms of interaction.

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 for 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 drugs—sulfonylurea derivatives.

If you are taking any other medicinal products, you must inform your physician.

Special precautions for use.

The drug should not be applied to large areas of skin.

Use during pregnancy or breastfeeding.

During pregnancy and breastfeeding, the drug should be used only if 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.

No effect.

Method of Administration and Dosage

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

Children

Do not use in children under 12 years of age.

Overdose

When large doses are applied, keratolytic effects and allergic reactions may be intensified. In such cases, the medication should be washed off with water and medical advice should be sought. Symptomatic therapy is recommended.

Side effects.

Possible skin reactions: dryness, peeling, irritation, contact dermatitis, allergic reactions (urticaria, itching), which may require discontinuation of the drug.

With prolonged use, systemic absorption of the drug may occur, leading to side effects typical of salicylates: tinnitus, dizziness, epigastric pain, nausea, vomiting, acidosis, rapid breathing.

In case of any adverse events, consult a physician immediately!

Shelf life. 3 years.

Do not use the medicinal product 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 bottles.

Supply category. Over-the-counter.

Manufacturer. JSC “FITOPHARM”.

Manufacturer’s address and location of business activity.

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing authorization holder. JSC “FITOPHARM”.

Address of the marketing authorization holder.

12 Almatinska Street, Kyiv, 02092, Ukraine.