SULFUR OINTMENT SIMPLE

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SULPHUR OINTMENT SIMPLE (Unguentum sulfuratum simplex)

Composition:

Active substance: sulfur;

1 g of ointment contains 0.33 g of sulfur;

Excipients: soft white paraffin, purified water, emulsifier T2.

Pharmaceutical form. Ointment 33.3%.

Main physicochemical properties: yellowish-colored ointment.

Pharmacotherapeutic group.

Dermatological agents. Local antiparasitic, antimicrobial agents. Sulfur-containing preparations. ATC code D10AB02.

Pharmacological properties.

Pharmacodynamics.

Simple sulfur ointment has antimicrobial and antiparasitic effects. When sulfur interacts with organic substances, sulfides and pentathionic acid are formed, which exert an antiseptic effect.

Pharmacokinetics.

When simple sulfur ointment is applied topically, sulfur and white soft paraffin, its components, are practically not absorbed into the systemic circulation.

Clinical characteristics.

Indications.

Skin disorders – seborrhea, sycosis, mycoses, psoriasis. Treatment of scabies (as part of combination therapy).

Contraindications.

Hypersensitivity to the drug.

Interaction with other medicinal products and other types of interactions.

When used simultaneously with topical medicinal products, new compounds with unpredictable effects may form. Interaction of the ointment with oxidizing agents (hydrogen peroxide, potassium permanganate) may lead to chemical burns.

Special precautions for use.

Avoid contact of the ointment with mucous membranes and eyes. Hands should be thoroughly washed after application of the ointment.

Use during pregnancy or breastfeeding.

The safety and clinical efficacy of the medicinal product during pregnancy or breastfeeding have not been studied. Therefore, the ointment should be used during these periods only if 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.

The effect of the medicinal product on the ability to drive and operate machinery has not been described.

Method of Administration and Dosage

Apply simple sulfur ointment externally. Apply the ointment to affected areas of the skin 2–3 times a day. When treating scabies, the treatment regimen and requirements for adherence to personal hygiene rules are determined individually by a physician.

Children

Contraindicated for children under 3 years of age. For children aged 3 to 12 years, the drug should be used only upon a physician's recommendation, taking into account the benefit-risk ratio.

Overdose

Not observed.

Side effects.

Allergic reactions.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C; do not freeze. Keep out of reach of children.

Packaging.

25 g or 50 g in containers. 20 g or 40 g in aluminum tubes. 20 g, 25 g, or 40 g in laminated tubes. One tube per carton or without a carton.

Availability category. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.