Glycerol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLYCERIN (GLYCEROL)

Composition:

Active ingredient: 1 g of the preparation contains 0.85 g of distilled glycerin calculated as open 100% substance;

Excipient: purified water.

Pharmaceutical form. 85% solution for external use.

Main physicochemical properties: syrupy, oily to touch, colorless or almost colorless, transparent, highly hygroscopic liquid.

Pharmacotherapeutic group.
Emollient and protective agents. ATC Code D02A X.

Pharmacological properties.

Pharmacodynamics.

Glycerin exerts a softening effect on the skin. Glycerin is also used as a solvent for boric acid, borax, protargol, and tannin.

Glycerin hardly penetrates through the skin, but penetrates well through the mucous membranes.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For softening the skin and processing mucous membranes. As a base for preparing liniments and ointments.

Contraindications.

Hypersensitivity. Skin lesions present (cracks, open wounds).

Interaction with other medicinal products and other forms of interactions.

Unknown.

Instructions for use.

Do not violate the instructions for use of the medicinal product.

Use during pregnancy or breastfeeding.

The medicinal product may be used during pregnancy or breastfeeding only when the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence the reaction rate when driving vehicles or operating other machinery.

Has no effect.

Method of administration and dosage.

Apply externally to the skin and mucous membranes; apply 30% solution to dry skin (dilute the preparation with water in a 1:3 ratio).

Children.

The safety and efficacy of glycerin in children have not been established.

Overdose.

Not observed.

Side effects.

Not identified.

Reporting of adverse reactions after drug registration is highly important. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

5 years.

The medicinal product must not be used after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 g in bottles.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "FITOFARM".

Manufacturer's address and location of its operations.

Ukraine, 84500, Donetsk region, city of Bakhmut, Sybirtseva Street, 2.

Marketing Authorization Holder.

JSC "FITOFARM".

Address of the Marketing Authorization Holder.

Ukraine, 02100, city of Kyiv, Boulevard of the Supreme Council, building 7, floor 3, room 18.

In case of adverse reactions or questions regarding the safety, quality, and efficacy of this medicinal product, please contact the Pharmacovigilance Department of JSC "FITOFARM" at the following phone number: +38 (044) 390 52 96.

INSTRUCTIONS

for medical use of the medicinal product

GLYCERIN

(GLYCEROL)

Composition:

Active substance: 1 g of the preparation contains 0.85 g of purified glycerol, calculated as open 100% substance;

Excipient: purified water.

Pharmaceutical form. 85% solution for external use.

Main physicochemical properties: syrupy, oily to the touch, colorless or almost colorless, clear, very hygroscopic liquid.

Pharmacotherapeutic group.

Emollient and protective agents. ATC code D02AX.

Pharmacological properties.

Pharmacodynamics.

Glycerol exerts a softening effect on the skin. Glycerol is also used as a solvent for boric acid, borax, protargol, and tannin.

Glycerol hardly penetrates through the skin, but penetrates well through the mucous membranes.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For softening the skin and treatment of mucous membranes. As a base for the preparation of liniments and ointments.

Contraindications.

Increased individual sensitivity. Presence of skin injuries (cracks, open wounds).

Interaction with other medicinal products and other types of interactions.

Unknown.

Special precautions for use.

Do not violate the instructions for use of the medicinal product.

Use during pregnancy or breastfeeding.

The medicinal product should be used during pregnancy or breastfeeding only when the expected benefit for the mother outweighs the potential risk to the fetus or infant.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Apply externally to skin and mucous membranes; apply 30% solution to dry skin (dilute the preparation with water in a 1:3 ratio).

Children.

The safety and efficacy of glycerin in children have not been established.

Overdose.

Not reported.

Side effects.

Not identified.

Reporting of adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

5 years.

The medicinal product must not be used after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach and sight of children.

Packaging.

25 g in bottles.

Supply classification.

Over-the-counter (without prescription).

Manufacturer: JSC "FITOPHARM" (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of manufacturing site.

17, Chumatska Street, Boryspil, Kyiv region, 08303, Ukraine.

Marketing Authorization Holder:

JSC "FITOPHARM".

Address of the Marketing Authorization Holder:

7, B. Verkhovnoi Rady Street, building 7, floor 3, room 18, Kyiv, 02100, Ukraine.

In case of adverse reactions or questions regarding the safety, quality, and efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOPHARM" at the following phone number: +38 (044) 390 52 96.