DERMASAN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DERMASAN Dermasan

Composition:

Active substances:

1 ml of the preparation contains: glycerol, calculated as 85% - 0.25 g; ammonia solution 10% - 0.25 ml; ethanol 96% - 0.25 ml;

Excipient: purified water.

Pharmaceutical form. Topical liquid.

Main physicochemical properties: clear, colorless liquid with the odor of ammonia.

Pharmacotherapeutic group.

Protective and emollient agents. ATC code D02AX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product has anti-inflammatory and antiseptic effects and improves skin elasticity.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Used for dry skin and cracks of the hands.

Contraindications.

Hypersensitivity to the components of the drug; ulcerative, pustular, traumatic skin lesions of the hands.

Interaction with other medicinal products and other forms of interaction.

Interaction is unknown.

Special precautions for use.

Do not violate the instructions for use of the medicinal product. Avoid contact with eyes and mucous membranes. Do not use in case of nipple fissures.

In case of accidental contact of Dermasan with ocular mucous membranes, rinse repeatedly with water (for 15 minutes with 10-minute intervals) or with 3% boric acid solution. If the medicinal product enters the nose and pharynx, use 0.5% citric acid solution or natural fruit juices. In case of accidental ingestion – drink water, fruit juice, milk, preferably 0.5% citric acid solution or 1% acetic acid solution until complete neutralization of gastric contents.

Use during pregnancy or breastfeeding.

The use of this medicinal product is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

No influence on the ability to drive or operate machinery has been observed.

Method of Administration and Dosage.

For external use in adults. Apply the product by rubbing it into clean, soap-washed, and thoroughly towel-dried skin of the hands 2–3 times daily.

The duration of use is determined by the therapeutic effect achieved.

Children.

There is no experience with the use of the product for treatment in children.

Overdose.

Not observed.

Side effects.

Irritation, dermatitis, eczema at the application site, allergic reactions.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging. 50 ml in bottles; 50 ml or 100 ml in a bottle, 1 bottle per carton.

Supply category. Over-the-counter (without prescription).

Manufacturer.

JSC «FITOFARM».

Manufacturer's address and location of business activity.

Sibirtseva St., 2, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder.

JSC «FITOFARM».

Address of the Marketing Authorization Holder.

7, Verkhovnoyi Rady Blvd., 3rd floor, room 18, Kyiv, 020100, Ukraine.

INSTRUCTION

for medical use of the medicinal product

DERMASAN

Dermasan

Composition:

Active substances:

1 ml of the preparation contains: glycerol, calculated as 85% - 0.25 g; ammonia solution 10% - 0.25 ml; ethanol 96% - 0.25 ml;

Excipient: purified water.

Pharmaceutical form. Topical liquid.

Main physicochemical properties: clear, colorless liquid with the odor of ammonia.

Pharmaco-therapeutic group.
Emollient and protective agents. ATC code: D02AX.

Pharmacological properties.

Pharmacodynamics.

The medicinal product has anti-inflammatory and antiseptic effects, improves skin elasticity.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Used for dryness of the skin of the hands and cracks.

Contraindications.

Hypersensitivity to the components of the drug; ulcerative, pustular, traumatic skin lesions of the hands.

Interaction with other medicinal products and other forms of interaction.

Interaction is unknown.

Special precautions for use.

Do not violate the instructions for use of the medicinal product. Avoid contact with eyes and mucous membranes. Do not use in case of nipple fissures.

In case of accidental contact of Dermasan with ocular mucous membranes, rinse thoroughly with water several times (for 15 minutes with 10-minute intervals) or with 3% boric acid solution. If the medicinal product enters the nose or pharynx, use 0.5% citric acid solution or natural fruit juices. In case of accidental ingestion – drink water, fruit juice, or milk; preferably, 0.5% citric acid solution or 1% acetic acid solution until complete neutralization of gastric contents is achieved.

Use during pregnancy or breastfeeding.

The use of this medicinal product is not recommended during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

No influence on the ability to drive or operate machinery has been observed.

Method of Administration and Dosage

Apply externally to adults. Rub the product into clean, soap-washed, and thoroughly towel-dried skin of the hands 2–3 times daily.

The duration of use is determined by the achieved effect.

Children.

There is no experience with the use of the drug for treatment in children.

Overdose.

Not observed.

Side effects.

Irritation, dermatitis, eczema at the site of application, allergic reactions.

Shelf life. 2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging. 50 ml in bottles; 50 ml or 100 ml in a bottle, 1 bottle per carton.

Availability category. Over-the-counter.

Manufacturer. JSC «FITOPHARM» (responsible for batch release, excluding batch control/testing).

Manufacturer's address.

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

Marketing Authorization Holder.

JSC «FITOPHARM».

Address of the Marketing Authorization Holder.

7 Verkhovnoyi Rady Avenue, Building 7, 3rd floor, Room 18, Kyiv, Ukraine, 020100.