Vaseline

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VASELINE

Composition:

Active substance: vaseline; 1 tube contains 30 g of vaseline.

Pharmaceutical form. Ointment.

Main physico-chemical properties: semi-transparent, soft to the touch mass of white or almost white color; in molten state, slightly fluorescent in daylight.

Pharmacotherapeutic group.
Preparations with emollient and protective action. ATC code D02AC.

Pharmacological properties.

Pharmacodynamics.

Vaseline – a purified mixture of solid and liquid hydrocarbons obtained from petroleum. Vaseline has a softening effect on the skin.

When applied topically, vaseline is practically not absorbed into the systemic circulation.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For softening the skin of hands and face, including after exposure to adverse temperature factors.

Contraindications.

Individual hypersensitivity to the medicinal product.

Special precautions.

If necessary, after application of Vaseline, wipe off with a cotton or gauze swab and wash with warm water and soap.

Interaction with other medicinal products and other types of interactions.

As an inert substance, Vaseline does not interact with other medicinal products.

Special precautions.

Use during pregnancy or breastfeeding.

No contraindications.

Ability to affect reaction rate when driving or operating machinery.

No effect.

Method of administration and dosage.

Vaseline is applied externally. A small amount is applied to the affected area of skin and gently rubbed in.

Children.

There are no contraindications for use in children.

Overdose.

Not known.

Adverse reactions.

In individuals with increased sensitivity, irritation and allergic reactions are possible.

Reporting of adverse reactions after registration of the medicinal product is of great importance. It allows 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 of the medicinal product through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua .

Shelf life.

5 years.

Storage conditions.

In the original packaging, at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

30 g in tubes.

Availability classification.

Over-the-counter (without prescription).

Manufacturer.

JSC "FITOFARM"

Manufacturer's location and address of business activity.

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

Marketing Authorization Holder.

JSC "FITOFARM".

Address of the Marketing Authorization Holder.

Ukraine, 02100, city of Kyiv, Boulevard of the Verkhovna Rada, building 7, floor 3, room 18.

In case of adverse reactions or questions regarding safety, quality, and efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOFARM" at +38 (044) 390 52 96 or visit https://fitofarm.ua, go to the section "Pharmacovigilance", and choose a convenient method of communication.

INSTRUCTION

for medical use of the medicinal product

VASELINE

Composition:

Active ingredient: vaseline; 1 tube contains 30 g of vaseline.

Pharmaceutical form. Ointment.

Main physico-chemical properties: semi-transparent, soft to the touch mass of white or almost white color; in molten state, slightly fluorescent in daylight.

Pharmacotherapeutic group.

Emollient and protective agents. ATC code: D02AC.

Pharmacological properties.

Pharmacodynamics.

Vaseline – a purified mixture of solid and liquid hydrocarbons obtained from petroleum. Vaseline has a softening effect on the skin.

When applied topically, vaseline is practically not absorbed into the systemic circulation.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For softening the skin of hands and face, including after exposure to adverse temperature factors.

Contraindications.

Individual hypersensitivity to the medicinal product.

Safety precautions.

If necessary, after application of Vaseline, wipe off with a cotton or gauze swab and wash with warm water and soap.

Interaction with other medicinal products and other forms of interaction.

As an inert substance, Vaseline does not interact with other medicinal products.

Special precautions.

Use during pregnancy or breastfeeding.

No contraindications.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Dosage and Administration.

Vaseline is for topical use. Apply a small amount to the affected area of skin and rub in gently.

Children.

There are no contraindications for use in children.

Overdose.

Not known.

Side effects.

Irritation and allergic reactions are possible in individuals with increased sensitivity.

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

Shelf life.

5 years.

Storage conditions.

In the original packaging, at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

30 g in tubes.

Availability category.

Over-the-counter.

Manufacturer: JSC "FITOFARM"

(responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of its operations:

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

Marketing Authorization Holder:

JSC "FITOFARM".

Address of the Marketing Authorization Holder:

18, Premises, 3rd Floor, 7, Verkhovnoyi Rady Boulevard, Kyiv, 02100, Ukraine.

In case of adverse reactions or questions regarding safety, quality, or efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOFARM" at +38 (044) 390 52 96 or visit https://fitofarm.ua, go to the "Pharmacovigilance" section, and select your preferred method of communication.