ETHYL ALCOHOL 96 %

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SPIRITUS AETHYLICUS 96 % (ETHYL ALCOHOL 96 %)

Composition:

Active substance: ethanol;

not less than 95.1 % v/v (92.6 % w/w) and not more than 96.9 % v/v (95.2 % w/w) ethanol, and water.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: clear, colorless, volatile, flammable liquid. Hygroscopic.

Pharmacotherapeutic group.

Antiseptics and disinfectants.

ATC code D08AX08.

Pharmacological Properties.

Pharmacodynamics.

When applied externally, exerts antiseptic, disinfectant, and local irritant effects. Ethanol coagulates proteins and is active against gram-positive and gram-negative bacteria as well as viruses. Exerts a "tanning" effect on the skin and mucous membranes.

Pharmacokinetics.

Not absorbed through the skin when applied locally.

Clinical characteristics.

Indications.

For disinfection of hands.

Contraindications.

Hypersensitivity.

Should not be used in acute inflammatory skin conditions.

Children under 14 years of age.

Safety precautions.

If redness or skin irritation occurs, discontinue use and wash the area with water.

Avoid contact of the product with eyes.

Interaction with other medicinal products and other forms of interaction.

When ethanol is used topically, interactions with other medicinal products are unknown.

Special precautions.

Use during pregnancy or breastfeeding.

During pregnancy and breastfeeding, the use of this medicinal product is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate when driving or operating machinery.

No effect.

Method of administration and dosage.

Externally — apply to the skin using cotton swabs or wipes.

Children.

Not recommended for children under 14 years of age.

Overdose.

Cases of overdose are unknown with topical application.

Side effects.

With local application — irritation of the skin or mucous membranes.

If any adverse reactions occur, consult a physician.

Shelf life. 5 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children. Protect from fire.

Packaging. 50 ml in glass bottles stoppered with plugs and caps; in polymer bottles closed with dropper plugs and tamper-evident caps; in polymer bottles closed with tamper-evident caps. 100 ml in glass bottles stoppered with plugs and caps or aluminum caps; in polymer bottles closed with tamper-evident caps. 200 ml in glass jars or polymer bottles closed with tamper-evident caps. 0.5 L, 1 L, 2 L, 5 L, 10 L, or 20 L in cans closed with caps (for use in medical facilities).

Prescription status. Prescription only.

Manufacturer. Private joint-stock company pharmaceutical factory "Viola".

Manufacturer's location and address of business activity.

75 Amosova Street, Zaporizhzhia, Ukraine, 69063.