Salicylic acid

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SALICYLIC ACID

Composition:

Active substance: salicylic acid;

100 ml of solution contains 1 g of salicylic acid;

Excipient: ethanol 70%.

Pharmaceutical form. Topical solution, alcoholic.

Main physicochemical properties: Clear, colorless liquid.

Pharmacotherapeutic group. Dermatological preparations.

ATC code D01AE12.

Pharmacological properties.

Pharmacodynamics. Antiseptic agent. Exerts antimicrobial, irritant, and counterirritant effects when applied locally.

Pharmacokinetics. Not studied.

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 instructions for use of the medicinal product, as this may harm health.

Interaction with other medicinal products and other types of interactions.

Topical application 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 increasing their systemic absorption. In addition, salicylic acid may enhance the adverse effects of methotrexate and the hypoglycemic effect of oral antidiabetic sulfonylurea derivatives.

If you are taking any other medicinal products, be sure to inform your doctor.

Usage Notes.

Do not apply the medication to large areas of skin.

Use during pregnancy or breastfeeding.

The medication may be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction rate when driving or operating machinery.

Has no effect.

Method of administration and dosage.

Apply externally, wiping or rubbing the affected skin areas with a cotton swab soaked in the preparation, 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 of the drug are applied, keratolytic effect and allergic reactions may be intensified. In such a case, the drug should be washed off with water and medical advice should be sought. Symptomatic therapy.

Side effects

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

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

If any adverse events occur, medical advice should be sought immediately!

Shelf life. 3 years.

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

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

40 ml in bottles without carton boxes or in cardboard carton boxes.

Supply category. Over-the-counter.

Manufacturer/Marketing authorization holder.

LLC "Ternofarm".

Address of manufacturer and location of its business activity.

LLC "Ternofarm".

4 Fabrychna St., Ternopil, 46010, Ukraine.