CALENDULA OINTMENT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULA OINTMENT (CALENDULAE UNGUENTUM)

Composition:

Active ingredient: calendula tincture;

1 g of ointment contains calendula tincture (Calendulae tinctura) (1:10) (extraction solvent – ethanol 70%) – 0.1 g;

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

Pharmaceutical form. Ointment.

Main physico-chemical properties: yellowish ointment.

Pharmacotherapeutic group. Medicinal products promoting wound healing.

ATC code D03AX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product contains flavonoids, carotenoids, saponins, tannins, organic acids, and other compounds. Calendula ointment exerts antiseptic, anti-inflammatory, and reparative effects.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Burns, cuts, cracks, and other skin injuries.

Contraindications.

Hypersensitivity to the components of the medicinal product.

Safety precautions.

Avoid contact of the ointment with eyes. In case of accidental contact with eyes, rinse thoroughly with water and seek medical advice immediately.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

Should not be used in individuals who are prone to allergic reactions to medicinal products containing calendula.

Use during pregnancy or breastfeeding.

The safety and efficacy of the drug during pregnancy or breastfeeding have not been studied; therefore, it is not recommended for use in these patient groups.

Ability to affect reaction speed when driving or operating machinery.

Has no effect.

Dosage and Administration.

The medicinal product is for topical use.

Apply the ointment in a thin layer to affected areas (can be used under occlusive dressing). The duration of treatment is determined individually by a physician, depending on the nature and severity of the pathological process and the therapeutic response achieved.

Patients should consult a physician if symptoms do not resolve during treatment or if any adverse reactions occur.

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

Overdose.

Not reported. May result in an intensification of adverse reactions.

Side effects.

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

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC, in a place inaccessible to children.

Packaging.

25 g in a tube per carton.

Availability. Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4, Korolova St., Stanishivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.