Ichthammol ointment 10 %

I N S T R U C T I O N for medical use of the medicinal product ICHTHYOL OINTMENT 10% (Unguentum Ichthyoli 10%)

Composition:

Active substance: ichthammol;

1 g of ointment contains 0.1 g of ichthammol;

Excipient: white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: dark brown ointment with the odor of ichthammol.

Pharmacotherapeutic group. Antiseptics and disinfectants.

ATC code D08AX.

Pharmacological properties.

Pharmacodynamics.

The pharmacological properties of ichthammol ointment are determined by the action of biologically active substances of ichthammol. Ichthammol ointment exhibits antimicrobial (bactericidal and bacteriostatic), anti-inflammatory, and local analgesic effects.

Pharmacokinetics.

When applied topically, ichthammol ointment is practically not absorbed into the systemic circulation and does not produce resorptive effects.

Clinical characteristics.

Indications. Burns, eczema, erysipelas, neuralgia, arthritis.

Contraindications. Hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

When used simultaneously with topical medicinal products, new compounds with unpredictable effects may form. Incompatible with solutions of iodides, alkaloids, and heavy metal salts.

Special precautions for use.

Avoid contact of the ointment with mucous membranes. Hands should be thoroughly washed after application to prevent accidental transfer of residual ointment to eyes, nose, or mouth.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction rate when driving or operating machinery.

The effect of the medicinal product on the ability to drive or operate machinery has not been described.

Administration and dosage.

Apply the ointment externally. Apply the medication to the affected area 2–3 times daily, either openly or under an occlusive dressing. Duration of treatment is determined by the course of the disease and the therapeutic response.

Children.

Experience with use in children has not been described.

Overdose.

No cases of overdose have been reported.

Adverse Reactions.

Local or generalized allergic reactions may occur, including skin rashes, itching, burning, and skin redness, more frequently at the beginning of treatment or during prolonged use.

Shelf life. 5 years.

Storage conditions.

Store in the 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 or 30 g in aluminum or laminated tubes, in a carton or without a carton.

Supply category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and location.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

75 Amosova Akademika Street, Zaporizhzhia, 69063, Ukraine.