Calendula ointment

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CALENDULAE OINTMENT

Composition:

Active substance: Calendula tincture (Calendulae tinctura) (1:10) (extraction solvent – 70.0% ethanol (v/v)) 100 mg;

Excipients: consistent emulsion: purified water, soft white paraffin, emulsifier T-2, mineral oil.

Pharmaceutical form. Ointment.

Main physicochemical properties: thick homogeneous mass of light yellow color with a grayish or greenish tint.

Pharmacotherapeutic group.

Medicinal products promoting wound healing. ATC code D03AX.

Pharmacological properties.

The drug exerts anti-inflammatory, reparative, and antiseptic effects. These effects are due to its rich content of substances (carotenoids, flavonoids, saponins, tannins, triterpene glycosides, organic acids, ascorbic acid) that enhance granulation growth, improve epithelialization, and strengthen local defense mechanisms.

Clinical characteristics.

Indications.

Burns, cuts, cracks, and other skin injuries.

Contraindications.

Increased individual sensitivity to the components of the drug.

Special 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.

Instructions for use.

Do not use in individuals prone to allergic reactions to calendula preparations.

Use during pregnancy or breastfeeding.

Calendula ointment is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

No effect.

Dosage and Administration.

The medication is intended for topical use. Apply the ointment as a thin layer to affected areas (can be used under occlusive dressing). The duration of treatment is determined individually by a physician and depends on the nature and severity of the pathological process, as well as the therapeutic response achieved.

Children.

The safety and efficacy of the ointment in children under 12 years of age have not been established; therefore, the medication may be prescribed to this patient group only after careful assessment of the risk-benefit ratio (under physician's supervision).

Overdose.

Not reported. An increased risk of adverse reactions may occur.

Side effects.

In case of individual hypersensitivity, allergic reactions may occur, including skin redness, rash, itching, angioedema.

Shelf life.

3 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

40 g in jars, 30 g in tubes, 30 g in tubes № 1.

Dispensing category.

Over-the-counter.

Manufacturer.

JSC «Lubnipharm».

Manufacturer's address and place of business.

16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.