ETHYLSEPT 96

INSTRUCTION
for medical use of medicinal product

ETHYLOSEPT 96
(ETHYLOSEPT 96)

Composition:

Active ingredient: ethanol;

not less than 95.1% v/v (92.6% w/w) and not more than 96.9% v/v (95.2% w/w) of ethanol, as well as 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 and viruses. Exerts an astringent effect on the skin and mucous membranes.

Pharmacokinetics.

When applied locally, it is not absorbed through the skin.

Clinical characteristics.

Indications.

Disinfection of hands.

Contraindications.

Increased individual sensitivity. Should not be used in acute inflammatory skin conditions. Children under 14 years of age.

Special precautions.

If redness or irritation of the skin occurs, application must be discontinued and the liquid washed off with water.

Avoid contact with eyes.

Interaction with other medicinal products and other forms of interaction.

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

Special instructions.

Use during pregnancy or breastfeeding.

During pregnancy and breastfeeding, the product may be used only when 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.

For external use – applied to the skin using cotton swabs or wipes.

Children.

Do not use in children under 14 years of age.

Overdose.

With external use, cases of overdose are unknown.

Adverse reactions.

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

If any adverse events occur, consult a physician.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C, away from fire.

Keep out of reach of children.

Packaging.

100 ml in glass bottles. 1 L, 5 L in glass jars, 1 L,
5 L, 10 L, 20 L in polymer cans (for supply to medical institutions).

Prescription status.

By prescription only.

Manufacturer.

JSC "Biolyk".

Manufacturer's address and place of business.

Ukraine, 24321, Vinnitsa region, city of Ladijyn, Nezalejnosti St., 131, Sh.

Marketing Authorization Holder.

Private Entrepreneur Knish Vitaliy Volodymyrovych.

Address of the Marketing Authorization Holder.

Ukraine, 49051, Dnipropetrovsk region, city of Dnipro, Osinnia St., 19.