Ethanol 95% (Solution, Concentrate) Instructions for Use

Instructions
Dosage forms

ATC Code

D08AX08 (Ethanol)

Active Substance

Ethanol (Grouping name)

Clinical-Pharmacological Group

Antiseptic for external use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

An antiseptic agent. When applied externally, it exerts an antimicrobial effect. It is active against gram-positive and gram-negative bacteria and viruses. It denatures microbial proteins.

Antiseptic activity increases with increasing ethanol concentration.

For skin disinfection, a 70% solution is used, which penetrates into the deeper layers of the epidermis better than a 95% solution, which has a tanning effect on the skin and mucous membranes.

When used systemically, it has the ability to cause analgesia and general anesthesia. The cells of the central nervous system are most sensitive to ethanol, especially the cells of the cerebral cortex, upon which ethanol exerts a characteristic alcoholic excitation associated with the weakening of inhibition processes. This is followed by a weakening of excitation processes in the cortex, depression of the spinal cord and medulla oblongata with suppression of the respiratory center activity.

It is a solvent for a number of medicinal products, as well as an extractant for a number of substances contained in medicinal plant materials.

Pharmacokinetics

Ethanol is metabolized in the liver with the participation of the isoenzyme CYP2E1, of which it is an inducer.

Indications

Treatment of initial stage inflammatory skin diseases (furuncle, panaritium, mastitis); surgical hand scrubbing (Fürbringer’s method, Alfred’s method), surgical field preparation (including in persons with hypersensitivity to other antiseptics, in children, and during operations on areas with thin skin in adults – in the neck and face area).

As a counterirritant medicinal product.

For the preparation of dosage forms for external use, tinctures, extracts.

Preservation of biological material.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
L02	Cutaneous abscess, furuncle and carbuncle
L03.0	Cellulitis of finger and toe
L60	Disorders of nails
N61	Inflammatory diseases of the breast
Z29.8	Other specified prophylactic measures
Z51.4	Preparatory procedures for subsequent treatment or examination, not elsewhere classified

ICD-11 code	Indication
1B70.1	Streptococcal cellulitis of the skin
1B70.2	Staphylococcal cellulitis of the skin
1B70.Z	Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B75.0	Furuncle
1B75.1	Carbuncle
1B75.2	Furunculosis
1B75.3	Pyogenic skin abscess
EE1Z	Diseases of the nails or nail bed, unspecified
GB21.Z	Inflammatory diseases of the breast, unspecified
QB9A	Preparatory procedures for subsequent treatment
QC05.Z	Prophylactic measures, unspecified

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.

For skin disinfection, use a 70% solution; dilute the 95% concentrate accordingly with sterile water.

Apply a sufficient amount to the skin area using sterile gauze or a cotton swab; rub thoroughly for at least 30 seconds and allow to air dry.

For surgical hand scrubbing, follow the Fürbringer or Alfred method protocols; scrub for the full recommended duration.

For preoperative skin preparation, apply generously to the surgical site using a concentric circular motion; repeat application as mandated by surgical protocol.

For treating initial inflammatory skin lesions (e.g., furuncle, panaritium), apply the 70% solution to the affected area 2-3 times daily.

As a counterirritant, apply a compress with the appropriate dilution to the intact skin surrounding the inflammation.

For preservation of biological material, use the 95% concentrate as specified by the laboratory protocol.

When preparing extemporaneous dosage forms (tinctures, extracts), use the concentration specified in the official formulary or manufacturing instructions.

Avoid contact with eyes and mucous membranes.

Do not apply to large areas of damaged skin or under occlusive dressings due to risk of systemic absorption.

Adverse Reactions

Allergic reactions, skin burns, hyperemia and soreness of the skin at the site of compress application. When applied externally, it is partially absorbed through the skin and mucous membranes and can exert a systemic toxic effect (CNS depression).

Contraindications

Hypersensitivity to ethanol.

Pediatric Use

Ethanol, when applied externally, is partially absorbed through the skin and mucous membranes, which should be taken into account when used in children.

Special Precautions

It should not be taken orally during treatment with medicinal products.

Ethanol, when applied externally, is partially absorbed through the skin and mucous membranes, which should be taken into account when used in children.

Drug Interactions

With concurrent use, it enhances the effect of drugs that have a depressant effect on the central nervous system, cardiovascular system, and respiratory center.

When taken orally with drugs that have an inhibitory effect on the enzyme aldehyde dehydrogenase (which is involved in the metabolism of ethyl alcohol), the concentration of ethanol’s metabolite, acetaldehyde, increases, causing facial flushing, nausea, vomiting, general malaise, tachycardia, and decreased blood pressure.

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

Rx Only

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

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Ethanol 95% [Aptechny Sklad Ryazan-Farmatsiya, SUE (Russia)]
Solution for external use and preparation of medicinal forms 95%: bottle 50 ml or 100 ml, canisters 10 L, 21.5 L or 31.5 L

Marketing Authorization Holder

Aptechny Sklad Ryazan-Farmatsiya, SUE (Russia)

Dosage Form

Ethanol 95%

Solution for external use and preparation of medicinal forms 95%: bottle 50 ml or 100 ml, canisters 10 L, 21.5 L or 31.5 L

Dosage Form, Packaging, and Composition

Solution for external use and preparation of medicinal forms 95% is transparent, colorless, mobile, volatile, with a characteristic alcoholic odor and burning taste.

	1 L
Ethanol	95%

100 ml – glass bottles (for hospitals).
100 ml – dark glass bottles (1) (for hospitals) – cardboard packs.
10 L – polyethylene canisters (for hospitals).
21.5 L – polyethylene canisters (for hospitals).
31.5 L – polyethylene canisters (for hospitals).
50 ml – dark glass bottles (1) (for hospitals) – cardboard packs.

Ethanol 95% [Vladivostok Pharmaceutical Factory, JSC (Russia)]
Solution for external use and preparation of medicinal forms 95%: fl. 50 ml or 100 ml, p/e canisters 10 L, 21.5 L and 31.5 L

Marketing Authorization Holder

Vladivostok Pharmaceutical Factory, JSC (Russia)

Dosage Form

Ethanol 95%

Solution for external use and preparation of medicinal forms 95%: fl. 50 ml or 100 ml, p/e canisters 10 L, 21.5 L and 31.5 L

Dosage Form, Packaging, and Composition

Solution for external use and preparation of medicinal forms 95% is transparent, colorless, mobile, volatile, with a characteristic alcoholic odor and burning taste.

	1 L
Ethanol	95%

100 ml – glass bottles (for hospitals)..
100 ml – dark glass bottles (1) (for hospitals) – cardboard packs.
10 L – polyethylene canisters (for hospitals)..
21.5 L – polyethylene canisters (for hospitals)..
31.5 L – polyethylene canisters (for hospitals)..
50 ml – dark glass bottles (1) (for hospitals) – cardboard packs.

Ethanol 95% [Voronezh Pharmacy State Unitary Enterprise of Voronezh Region (Russia)]
Solution for external use and preparation of medicinal forms 95%: bottle 50 ml or 100 ml, canisters 10 L, 21.5 L and 31.5 L

Marketing Authorization Holder

Voronezh Pharmacy State Unitary Enterprise of Voronezh Region (Russia)

Dosage Form

Ethanol 95%

Solution for external use and preparation of medicinal forms 95%: bottle 50 ml or 100 ml, canisters 10 L, 21.5 L and 31.5 L

Dosage Form, Packaging, and Composition

Solution for external use and preparation of medicinal forms 95% is transparent, colorless, mobile, volatile, with a characteristic alcoholic odor and burning taste.

	1 L
Ethanol	95%

	1 fl.
Ethanol 95%	50 ml

50 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (35) – cardboard boxes (for hospitals).
50 ml – glass bottles (35) – cardboard cartons (for hospitals).

Ethanol medical [Rosbio, LLC (Russia)]
Concentrate for preparation of solution for external use 95%: bottle 50 ml or 100 ml, container 100 ml, 1 L or 5 L, canisters 5, 10 or 50 pcs.

Marketing Authorization Holder

Rosbio, LLC (Russia)

Dosage Form

Ethanol medical

Concentrate for preparation of solution for external use 95%: bottle 50 ml or 100 ml, container 100 ml, 1 L or 5 L, canisters 5, 10 or 50 pcs.

Dosage Form, Packaging, and Composition

Concentrate for preparation of solution for external use 95% is transparent, colorless, with a characteristic alcoholic odor.

	1 fl.
Ethanol 95%	100 ml

50 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) – cardboard packs.
100 ml – dark glass jars (1) – cardboard packs.
5 L – polymer bottles.
100 ml – dark glass bottles (1) – packs.
1 L – polymer bottles.
5 L – polymer canisters.
10 L – polymer canisters.
20 L – polymer canisters.
30 L – polymer canisters.