Ethyl alcohol 96 %

INSTRUCTION
for medical use of medicinal product

ETHYL ALCOHOL 96 %
(ETHYL ALCOHOL 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) ethanol, as well as water.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: clear, colorless, volatile, highly 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 an astringent effect on the skin and mucous membranes.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Skin disinfection of hands.

Contraindications.

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

Special precautions.

In case of redness and skin irritation, discontinue use and wash the area with water.

Avoid contact with eyes.

Interaction with other medicinal products and other forms of interactions.

When ethanol is applied 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 affect 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.

Not to be used in children under 14 years of age.

Overdose.

With external use, cases of overdose are unknown.

Side effects.

With local application – skin or mucous membrane irritation.

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 bottles; 1 L,
5 L, 10 L, 20 L in polymer canisters (for supply to medical institutions).

Prescription status.

By prescription only.

Manufacturer.

JSC "Biolyk".

Manufacturer's name and address of place of business.

Ukraine, 24321, Vinnytsia region, city of Ladijyn, Nezalezhnosti St., 131, Sh.

Marketing Authorization Holder.

FOP Knish Vitaliy Volodymyrovych.

Address of the Marketing Authorization Holder.

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