MC Peel (Solution) Instructions for Use

Marketing Authorization Holder

LABORATORIYA TOSKANI, LLC (Russia)

ATC Code

D01AE12 (Salicylic acid)

Active Substances

Salicylic acid (USP)

Phenol (USP)

Dosage Forms

	MC Peel	Solution for external use 25 g+3 g: 30 ml bottle
		Solution for external use 30 g+3 g: 30 ml bottle
		Solution for external use 35 g+3 g: 30 ml bottle
		Solution for external use 45 g+3 g: 30 ml bottle

Dosage Form, Packaging, and Composition

Excipients : glycerol 8 g, propylene glycol 2 g, purified water up to 100 g.

30 ml – dark glass bottles (1) – cardboard packs.

Excipients : glycerol 8 g, propylene glycol 2 g, purified water up to 100 g.

30 ml – dark glass bottles (1) – cardboard packs.

Excipients : glycerol 8 g, propylene glycol 2 g, purified water up to 100 g.

30 ml – dark glass bottles (1) – cardboard packs.

Excipients : glycerol 8 g, propylene glycol 2 g, purified water up to 100 g.

30 ml – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with keratolytic and antimicrobial action for external use

Pharmacotherapeutic Group

Keratolytic agent

Pharmacological Action

Phenol is an antiseptic agent. It has bactericidal activity against vegetative forms of bacteria (primarily aerobic) and fungi, has a weak effect on spores; exerts a disinfectant action. It interacts with the proteins of the microbial cell and causes their denaturation, disrupts the colloidal state of the cell, dissolves in the lipids of the cell membrane and increases its permeability, and affects redox processes. In a 1.25% solution, most microorganisms die within 5-10 minutes at room temperature. It has an irritating and cauterizing effect on the skin and mucous membranes.

The bactericidal effect is enhanced in an acidic environment and with increasing temperature.

Salicylic acid has antiseptic, keratolytic, locally irritating, and anti-inflammatory actions. It suppresses the secretion of sebaceous and sweat glands. In low concentrations, it has a keratoplastic effect, and in high concentrations, it has a keratolytic effect. It has weak antimicrobial activity.

The combined action of both active components results in a reduction in the activity of the sebaceous glands, swelling, pain, hyperemia in the area of inflammatory infiltrates, improvement of microcirculation, and thereby activation of reparative processes in the skin, which prevents scar formation. The minimal skin trauma, which is inevitable when exposed to phenol, promotes the activation of metabolic processes, and, as a consequence, an increase in local immunity, synthesis of elastin and collagen fibers, which leads to the gradual resorption of cyanotic congestive spots, leveling of atrophic scars from the inside, and significant improvement in skin texture.

Pharmacokinetics

Phenol is easily absorbed through the skin and mucous membranes. With systemic absorption, it has a toxic effect. 20% of the dose is oxidized. It is excreted by the kidneys. With external use of salicylic acid, systemic absorption is possible.

Indications

Symptomatic therapy of the following diseases

• Acne vulgaris;
• Seborrheic dermatitis;
• Consequences of previously suffered acne with developed non-coarse scars and hyperpigmentation;
• Actinic dermatitis;
• Keratosis.

Prevention and correction of cosmetic skin defects.

Preparation for deep dermabrasion and skin-plastic surgeries.

ICD codes

Dosage Regimen

Since the effectiveness of the drug directly depends on its exposure time on the skin (the longer the drug remains on its surface, the deeper its penetration), for each specific patient, depending on the skin type and its sensitivity, the exposure time is selected individually. This selection is carried out by a doctor.

The duration of exposure also depends on the set goals. The procedure is carried out for a longer time if the goal is deep penetration of the drug into the epidermis.

Before applying the drug, it is necessary to clean and degrease the skin.

The solution is applied to the affected areas of the skin with a clean cotton swab, and the exposure time can vary widely, on average from 1 to 5 minutes.

After the procedure, an oily gel is applied and then the usual post-peeling skin care is performed.

Adverse Reactions

Individual intolerance is possible; locally – itching, burning, rash.

Allergic reactions.

Contraindications

• Bacterial, viral, or fungal infections of the facial skin;
• Violation of the integrity of the epidermal layer of the skin;
• Couperose;
• Telangiectasias;
• Renal and hepatic insufficiency;
• Severe diseases of the cardiovascular system;
• Pollinosis;
• Bronchial asthma;
• Temporary period (less than a week) after epilation and other invasive procedures;
• Hypersensitivity to any of the components of the drug;
• Children under 18 years of age.

Use in Pregnancy and Lactation

It is not recommended to use the drug during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

The drug must not be allowed to get on the mucous membranes, especially on the mucous membrane of the eyes. In case of contact, immediately rinse the eyes with plenty of water and consult an ophthalmologist.

The drug should not be applied to birthmarks or warts.

Effect on the ability to drive vehicles or operate machinery

No effect.

Overdose

Since the procedure is performed by a doctor, with the recommended method of application, overdose is possible only with accidental application of large amounts of the drug to extensive areas of the skin.

Symptoms burning, hyperemia, anesthesia of the affected area.

Treatment treat the skin with a swab with vegetable oil or polyethylene glycol (do not use petroleum jelly), symptomatic therapy.

Drug Interactions

Salicylic acid may increase the permeability of the skin to other topical drugs and thereby enhance their absorption. Absorbed Salicylic acid may enhance the side effects of methotrexate and oral hypoglycemic drugs, sulfonylurea derivatives. The solution is pharmaceutically incompatible with resorcinol (forms melting mixtures) and zinc oxide (insoluble zinc salicylate).

Storage Conditions

In a place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

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.