CALENDULA OINTMENT

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA OINTMENT (Unguentum Calendulae)

Composition:

Active substance: Calendula tincture;

1 g of ointment contains 0.1 g of Calendula tincture;

Excipients: white soft paraffin, purified water, emulsifier T-2.

Pharmaceutical form. Ointment.

Main physicochemical properties: yellowish-colored ointment.

Pharmacotherapeutic group. Agents promoting wound healing. ATC code D03AX.

Pharmacological properties.

Pharmacodynamics.

Calendula ointment contains flavonoids, carotenoids, saponins, tannins, organic acids, and other compounds. It has antiseptic, anti-inflammatory, and reparative properties.

Clinical characteristics.

Indications. Burns, cuts, skin fissures, purulent wounds.

Contraindications. Increased individual sensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interactions.

Not established.

Special precautions for use.

Do not use in individuals prone to allergic reactions to calendula preparations. Avoid contact of the ointment with eyes. In case of accidental contact with eyes, rinse thoroughly with water and seek immediate medical advice.

Use during pregnancy or breastfeeding.

Safety and clinical efficacy of the medicinal product during pregnancy or breastfeeding have not been studied; therefore, it is not recommended for use in these patient groups.

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

Method of Administration and Dosage.

Apply the ointment in a thin layer to affected areas (can be used under occlusive dressing). The duration of treatment is determined individually by the physician and depends on the nature and severity of the pathological process or until the desired effect is achieved.

Children.

The safety and efficacy of the ointment in children under 12 years of age have not been established; therefore, the use of the drug in this patient category is allowed only after careful assessment of the risk-benefit ratio (under physician's prescription).

Overdose . Not reported. Possible intensification of adverse reactions.

Side effects.

Allergic reactions may occur in individuals with hypersensitivity, including skin redness, rash, itching, and angioedema.

Shelf life. 2 years 6 months.

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

Packaging. 40 g in containers; 20 g or 30 g in aluminum or laminated tubes.

1 tube per carton or without carton.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address.

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