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.
| 100 g | |
| Formic acid | 1.4 g |
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
| ICD-10 code | Indication |
| M13.9 | Arthritis, unspecified |
| M19.9 | Unspecified arthrosis |
| M25.5 | Pain in joint |
| M65 | Synovitis and tenosynovitis |
| M70 | Soft tissue disorders related to use, overuse, and pressure |
| M71 | Other bursopathies |
| M75.0 | Adhesive capsulitis of shoulder |
| M79.1 | Myalgia |
| M79.2 | Neuralgia and neuritis, unspecified |
| ICD-11 code | Indication |
| 8E4A.1 | Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system |
| FA0Z | Osteoarthritis, unspecified |
| FA2Z | Inflammatory arthropathies, unspecified |
| FB40.Z | Tenosynovitis, unspecified |
| FB50.1 | Bursitis associated with use, overuse or pressure |
| FB50.Z | Bursitis, unspecified |
| FB53.0 | Adhesive capsulitis of shoulder |
| FB56 | Specified soft tissue diseases, not elsewhere classified |
| FB56.2 | Myalgia |
| ME82 | Pain in joint |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and 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.
Medical Disclaimer