Medifox^® (Concentrate) Instructions for Use

Marketing Authorization Holder

Fox And Co Npc, LLC (Russia)

ATC Code

P03AC04 (Permethrin)

Active Substance

Permethrin (Rec.INN registered by WHO)

Dosage Form

Medifox®

Concentrate for the preparation of emulsion for external use 5%: amp. 2 ml, dropper bottles 24 ml, bottles 500 ml or 1000 ml

Dosage Form, Packaging, and Composition

Concentrate for the preparation of emulsion for external use 5% in the form of a transparent colorless or light-yellow liquid.

Excipients: hydrogenated castor oil – 7.5 g, butyl acetate – 0.25 g, ethanol 96% – 87.25 g.

2 ml – ampoules (2) – contour cell packaging.
2 ml – polymer ampoules (2) – cardboard boxes.
24 ml – dropper bottles (2) – cardboard boxes.
500 ml – polymer bottles.
1000 ml – polymer bottles.

Clinical-Pharmacological Group

Scabies and pediculosis treatment drug

Pharmacotherapeutic Group

Ectoparasiticide

Pharmacological Action

Antiparasitic agent. It disrupts the permeability of nerve cell membranes to cations in insects.

It is effective against scabies mites, as well as nits, larvae, and adult head and pubic lice.

It has low toxicity for warm-blooded animals and humans; when applied to the skin in recommended doses and concentrations, it does not have cutaneous-resorptive, local irritant, or sensitizing effects.

Indications

• Scabies, an infestation caused by the Sarcoptes scabiei mite.
• Pediculosis, including infestations of the scalp (head lice) and pubic area (pubic lice).

ICD codes

Dosage Regimen

Apply externally only after dilution. Prepare a 0.4% working emulsion by mixing one volume of the 5% concentrate with ten volumes of warm water.

For scabies, apply the prepared emulsion to the entire body, excluding the face and scalp. Wash off after 24 hours. A single application is usually sufficient.

For pediculosis, moisten hair and scalp with the emulsion, leave for 20-40 minutes, then rinse with warm water and shampoo. Use a fine-toothed comb to remove dead lice and nits.

Adverse Reactions

Rarely, mild and transient burning, stinging, itching, tingling, or numbness may occur at the application site.

Allergic reactions, including skin rash, redness, and swelling, are possible in individuals with hypersensitivity to the active substance or excipients. Discontinue use if such reactions occur.

Contraindications

• Known hypersensitivity to permethrin, other pyrethroids, or any component of the formulation.
• Use in children under 1 year of age due to immature skin barrier and increased risk of systemic absorption.

Use in Pregnancy and Lactation

During pregnancy, 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. If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Contraindicated for use in children under 1 year of age.

Special Precautions

Treatment should be carried out in a well-ventilated area or outdoors.

Avoid contact of the product with the mucous membranes of the eyes, nose, oral cavity, as well as the mucous membrane of the external genitalia.

In case of contact with mucous membranes, rinse them with running water.

After using the product, wash your hands with warm water and soap.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.