Formic acid spiritus Renewal (Solution) Instructions for Use

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

ATC Code

M02AX10 (Other drugs)

Active Substance

Formic acid (BP British Pharmacopoeia)

Dosage Form

Formic acid spiritus Renewal

Alcohol 1.4% topical solution: 25 mL bottle

Dosage Form, Packaging, and Composition

Topical alcohol solution in the form of a transparent, colorless liquid with a characteristic odor.

Excipients: ethanol 70% – 98.6 g.

25 ml – bottles – cardboard packs.
21.5 l – canisters.

Clinical-Pharmacological Group

Analgesic and local anesthetic agent for external use

Pharmacotherapeutic Group

Drugs for external use for muscle and joint pain; other drugs for external use for muscle and joint pain

Pharmacological Action

A local irritant agent that has a counterirritant effect.

It excites the sensitive receptors of the skin, causes vasodilation, and improves tissue trophism.

Indications

As part of complex therapy for neuralgia, arthralgia, myalgia, nonspecific mono- and polyarthritis, periarthritis.

ICD codes

Dosage Regimen

Apply the solution externally only. Use a small amount on the affected area.

Rub the solution gently into the skin until fully absorbed. Apply one to three times daily.

The duration of treatment depends on the therapeutic response and should not exceed 10 days without medical consultation.

Wash hands thoroughly with soap and water immediately after application. Avoid contact with eyes and other mucous membranes.

If the condition worsens or no improvement is seen after 3-5 days of use, discontinue the product and consult a physician.

Do not apply to damaged skin, open wounds, or areas with rashes or inflammation.

Do not use with occlusive dressings or bandages that do not allow air to circulate.

Do not exceed the recommended frequency of application.

Adverse Reactions

Possible skin hyperemia and itching, allergic reactions.

Contraindications

Hypersensitivity to formic acid; impaired skin integrity or inflammatory skin diseases at the site of intended application (including dermatitis, eczema); pregnancy, breastfeeding period; children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Pediatric Use

Use is contraindicated in children and adolescents under 18 years of age.

Special Precautions

Formic acid preparations should not be applied to mucous membranes and weeping wounds.

Drug Interactions

When used concomitantly with topical preparations containing organic compounds, new compounds may form and denaturation of protein components may be observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.