Mastodon

Sulfuric ointment simplex (Ointment) Instructions for Use

ATC Code

P03AA (Sulfur-containing compounds)

Active Substance

Precipitated sulfur (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Scabies treatment drug

Pharmacotherapeutic Group

Means for the destruction of ectoparasites (including scabies mites), insecticides and repellents; means for the destruction of ectoparasites, including scabies mites; other means for the destruction of ectoparasites, including scabies mites

Pharmacological Action

When applied externally, sulfur interacts with organic substances, forming sulfides and pentathionic acid, which exert antimicrobial and antiparasitic action.

Indications

  • For the treatment of scabies.

ICD codes

ICD-10 code Indication
B86 Scabies
ICD-11 code Indication
1G04 Scabies

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the ointment externally once daily in the evening for five consecutive days as a course of treatment.

Thoroughly rub the preparation over the entire skin surface of the body, excluding the head and face. Pay special attention to areas between fingers, toes, wrists, axillae, and other skin folds.

Do not wash hands for three hours after application; reapply the ointment to hands after every subsequent washing. Re-treat any other skin areas if the ointment is accidentally washed off.

Adverse Reactions

Local skin reactions, including itching, redness, burning, or dermatitis, may occur.

Allergic reactions, such as skin rash or contact hypersensitivity, are possible. Discontinue use if signs of a severe allergic reaction appear.

Drug Interactions

Avoid concurrent topical application with other medicated skin products, especially those containing abrasive or peeling agents, as this may increase skin irritation.

Concomitant use with other topical scabicides or pediculicides is not recommended due to the potential for enhanced local adverse effects.

Contraindications

  • Hypersensitivity to sulfur or any component of the ointment.
  • Known history of allergic reaction to sulfur-containing preparations.
  • Contraindicated in pediatric patients as specified for this specific dosage form; consult the package leaflet for age restrictions.

Overdose

Excessive topical application may lead to intensified local adverse reactions, including severe skin irritation, inflammation, or dermatitis.

In case of accidental ingestion, seek immediate medical attention. Symptoms of ingestion may include gastrointestinal irritation and sulfur dioxide release, which can be toxic.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the sulfur drug leaflets regarding contraindications for the use of specific sulfur dosage forms in children of different ages.

Special Precautions

Hands should not be washed for 3 hours after applying the product; subsequently, hands are treated with the product after each washing. If the ointment is washed off from other areas of the skin, they should also be re-treated. The product is completely washed off the skin on the fifth day of treatment.

Storage Conditions

Store at 8°C (46°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Murom Instrument-Making Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Sulfuric ointment simplex Ointment for external use 33.33 g/100 g: 25 or 40 g tubes

Dosage Form, Packaging, and Composition

Ointment for external use yellow in color.

100 g
Precipitated sulfur 33.33 g

Excipients : emulsifier T2 – 6.67 g, petrolatum – 40 g, purified water – 20 g.

25 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Bottle OTC Icon Sulfuric ointment simplex Ointment for external use 33.33 g/100 g: jars or tubes 25 g

Dosage Form, Packaging, and Composition

Ointment for external use 100 g
Sulfur (Precipitated sulfur) 33.33 g

25 g – dark glass jars (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Tver Pharmaceutical Factory, PJSC (Russia)

Dosage Form

Bottle OTC Icon Sulfuric ointment simplex Ointment for external use 33.33 g/100 g: jars 25 g, 30 g, 40 g or 50 g, packages of 1, 36, 49 or 64 pcs., tubes 30 or 40 g

Dosage Form, Packaging, and Composition

Ointment for external use 100 g
Sulfur 33.33 g

25 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
40 g – dark glass jars (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
25 g – dark glass jars (36) – cardboard boxes.
25 g – dark glass jars (49) – cardboard boxes.
25 g – dark glass jars (64) – cardboard boxes.
50 g – dark glass jars (36) – cardboard boxes.
50 g – dark glass jars (49) – cardboard boxes.
50 g – dark glass jars (64) – cardboard boxes.
30 g – dark glass jars (36) – cardboard boxes.
30 g – dark glass jars (49) – cardboard boxes.
30 g – dark glass jars (64) – cardboard boxes.
40 g – dark glass jars (36) – cardboard boxes.
40 g – dark glass jars (49) – cardboard boxes.
40 g – dark glass jars (64) – cardboard boxes.
40 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Sulfuric ointment simplex Ointment for external use 33.33 g/100 g: jars 25 g or tubes 25 g

Dosage Form, Packaging, and Composition

Ointment for external use 100 g
Ground sulfur 33.33 g

25 g – dark glass jars (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Sulfuric ointment simplex Ointment for external use 33.3%: jars 15 g, 20 g, 25 g, or 30 g, tubes 25 g or 30 g

Dosage Form, Packaging, and Composition

Ointment for external use light yellow in color, homogeneous.

100 g
Sulfur (Precipitated sulfur) 33.3 g

Excipients : petrolatum – 40 g, emulsifier T-2 – 6.7 g, purified water – 20 g.

15 g – dark glass jars (1) – cardboard packs.
20 g – dark glass jars (1) – cardboard packs.
25 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Sulfuric ointment simplex Ointment for external use 33.33 g/100 g: jars 25 g

Dosage Form, Packaging, and Composition

Ointment for external use 100 g
Precipitated sulfur 33.33 g

25 g – dark glass jars (1) – cardboard packs.

Table of Contents

→ TABLE OF CONTENTS