Camphor ungentum (Ointment) Instructions for Use

Marketing Authorization Holder

Tver Pharmaceutical Factory, PJSC (Russia)

ATC Code

M02AX10 (Other drugs)

Active Substance

Camphor (Ph.Eur. European Pharmacopoeia)

Dosage Form

Camphor ungentum

Ointment for external use 10%: jar 25 or 50 g, tube 30 or 40 g

Dosage Form, Packaging, and Composition

Excipients: petrolatum 54 g, hard paraffin 8 g, anhydrous lanolin 28 g.

25 g – jars of orange glass (1) – cardboard packs.
50 g – jars of orange glass (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Analgesic and local anesthetic agent for external use

Pharmacotherapeutic Group

Local irritant of plant origin

Pharmacological Action

The drug of natural origin has antiseptic, local irritant, local analgesic, and anti-inflammatory effects.

By stimulating the sensitive nerve endings of the skin, it dilates blood vessels and improves the trophism of organs and tissues.

Pharmacokinetics

When applied to the skin surface, it is partially absorbed and undergoes oxidation.

The oxidation products combine with glucuronic acid and are excreted by the kidneys.

A part of camphor is excreted unchanged by the lungs and with bile.

Permeability through the blood-brain barrier and placental barrier is high; secretion with breast milk is high.

Indications

• Myalgia;
• Myositis;
• Arthralgia;
• Sciatica;
• Prevention of pressure sore formation.

ICD codes

Dosage Regimen

Apply the ointment externally only.

Use a small amount of ointment on the painful area.

Rub the ointment into the skin with light, massaging movements.

Apply the ointment two to three times daily.

For prevention of pressure sores, treat the skin two to three times per day.

Always wash hands thoroughly after each application.

The standard treatment course is 7 to 10 days.

Undergo repeated courses only on the recommendation of a physician.

Avoid contact with open wounds, eyes, and mucous membranes.

Discontinue use and consult a physician if skin irritation or allergic reactions occur.

Adverse Reactions

Allergic skin reactions (urticaria), skin irritation, headache, dizziness.

Contraindications

• Impaired skin integrity or inflammatory skin diseases at the site of intended application (including dermatitis, eczema);
• Pregnancy;
• Lactation period;
• Age under 18 years (due to lack of data);
• Hypersensitivity.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Avoid getting the drug on open wounds, in the eyes, and on mucous membranes.

Effect on the ability to drive vehicles and mechanisms

During the treatment period, caution should be exercised when driving motor vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

To date, no cases of overdose with the use of the drug have been reported.

Drug Interactions

None identified.

Storage Conditions

Store at a temperature from 12°C (53.6°F) to 15°C (59°F), in a place protected from light.

Shelf Life

Shelf life – 4 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.