Derma-Cap (Cream, Aerosol, Shampoo) Instructions for Use

Instructions
Dosage forms

ATC Code

D11AX12 (Zinc pyrithione)

Active Substance

Pyrithione zinc (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antiproliferative, antibacterial, and antifungal action for topical use

Pharmacotherapeutic Group

Other drugs used in dermatology

Pharmacological Action

An agent for external use. Activated zinc pyrithione possesses anti-inflammatory, antibacterial, and antifungal activity. Antifungal activity is particularly pronounced against Pityrosporum ovale and Pityrosporum orbiculare, which cause inflammation and excessive flaking in dandruff, seborrhea, psoriasis, and other skin diseases.

Zinc pyrithione exhibits antibacterial activity against a number of pathogenic microorganisms (streptococcus, staphylococcus, Pseudomonas aeruginosa and Escherichia coli, Proteus, etc.). Zinc pyrithione reduces the intracellular level of ATP, promotes depolarization of cell membranes, causing the death of fungi and bacteria.

Pharmacokinetics

When applied externally, activated zinc pyrithione is deposited in the epidermis and superficial layers of the dermis.

Systemic absorption occurs slowly. It is detected in the blood in trace amounts.

Indications

Psoriasis
Atopic dermatitis
Eczema
Neurodermatitis
Seborrheic dermatitis in adults and children from 1 year of age.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
L20.8	Other atopic dermatitis (neurodermatitis, eczema)
L21	Seborrheic dermatitis
L28.0	Lichen simplex chronicus (circumscribed neurodermatitis)
L30.0	Nummular eczema
L40	Psoriasis

ICD-11 code	Indication
9A06.70	Atopic eczema of the eyelids
EA80.0	Infantile atopic eczema
EA80.1	Childhood atopic eczema
EA80.2	Adult atopic eczema
EA80.Z	Atopic eczema, unspecified
EA81.Z	Seborrheic dermatitis, unspecified
EA82	Nummular dermatitis
EA83.00	Lichen simplex of vulva
EA83.01	Lichen simplex of male genital organs
EA83.02	Lichen simplex of perianal area
EA83.0Z	Lichen simplex of unspecified location
EA85.20	Atopic hand eczema
EA90.Z	Psoriasis, unspecified

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 cream, aerosol, or shampoo externally to the affected areas of the skin or scalp.

Determine the frequency of application and the duration of the treatment course individually based on the specific indication, the dosage form used, and the speed of achieving the desired clinical effect.

For the shampoo, apply to wet hair, lather, and leave on the scalp for several minutes before thoroughly rinsing.

For the aerosol, shake the can well before use and spray from a distance of 10-15 cm onto the affected skin areas.

Adverse Reactions

Rarely, local allergic reactions such as skin rash, itching, or redness may occur.

During the initial days of treatment, a transient burning sensation at the application site is possible; this reaction usually subsides on its own and does not necessitate discontinuation of therapy.

Discontinue use immediately and consult a physician if signs of a severe allergic reaction or significant skin irritation develop.

Drug Interactions

Avoid concurrent use with other topical medicinal products, especially those containing corticosteroids, unless explicitly directed by a physician.

Concomitant application may alter the absorption of either agent or increase the risk of local adverse reactions.

Maintain a time interval between the application of different topical preparations if combination therapy is deemed necessary.

Contraindications

Hypersensitivity to zinc pyrithione or any other component of the formulation.
Children under 1 year of age due to insufficient data on safety and efficacy in this age group.

Overdose

Topical application makes systemic overdose unlikely. Excessive external use may lead to intensified local adverse reactions, such as severe irritation, redness, or burning.

In case of accidental ingestion, seek immediate medical attention. Symptoms of ingestion may include gastrointestinal irritation. Provide symptomatic and supportive care.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, use is possible according to indications in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Contraindicated for use in children under 1 year of age.

Special Precautions

It is not recommended to combine treatment with zinc pyrithione with topical preparations containing corticosteroids.

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.

Medical Disclaimer

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

Derma-Cap [Tula Pharmaceutical Factory, LLC (Russia)]
Medicated shampoo 1%: bottle 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g, 120 g, 130 g, 140 g, 150 g, 160 g, 170 g, 180 g, 190 g, or 200 g

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Derma-Cap

Medicated shampoo 1%: bottle 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g, 120 g, 130 g, 140 g, 150 g, 160 g, 170 g, 180 g, 190 g, or 200 g

Dosage Form, Packaging, and Composition

Medicated shampoo in the form of a white suspension with a characteristic odor.

	1 g
Pyrithione zinc	10 mg

Excipients: sodium lauryl sulfate – 260 mg, glycerol – 100 mg, sodium chloride – 5 mg, diethanolamide of coconut oil fatty acids – 40 mg, purified water – up to 1 g.

20 g – polymer bottles (1) – cardboard packs.
25 g – polymer bottles (1) – cardboard packs.
30 g – polymer bottles (1) – cardboard packs.
35 g – polymer bottles (1) – cardboard packs.
40 g – polymer bottles (1) – cardboard packs.
45 g – polymer bottles (1) – cardboard packs.
50 g – polymer bottles (1) – cardboard packs.
55 g – polymer bottles (1) – cardboard packs.
60 g – polymer bottles (1) – cardboard packs.
65 g – polymer bottles (1) – cardboard packs.
70 g – polymer bottles (1) – cardboard packs.
75 g – polymer bottles (1) – cardboard packs.
80 g – polymer bottles (1) – cardboard packs.
85 g – polymer bottles (1) – cardboard packs.
90 g – polymer bottles (1) – cardboard packs.
95 g – polymer bottles (1) – cardboard packs.
100 g – polymer bottles (1) – cardboard packs.
110 g – polymer bottles (1) – cardboard packs.
120 g – polymer bottles (1) – cardboard packs.
130 g – polymer bottles (1) – cardboard packs.
140 g – polymer bottles (1) – cardboard packs.
150 g – polymer bottles (1) – cardboard packs.
160 g – polymer bottles (1) – cardboard packs.
170 g – polymer bottles (1) – cardboard packs.
180 g – polymer bottles (1) – cardboard packs.
190 g – polymer bottles (1) – cardboard packs.
200 g – polymer bottles (1) – cardboard packs.

Derma-Cap [Tula Pharmaceutical Factory, LLC (Russia)]
Cream for external use 0.2%: tubes from 10 g to 200 g

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Derma-Cap

Cream for external use 0.2%: tubes from 10 g to 200 g

Dosage Form, Packaging, and Composition

Cream for external use 0.2% white or white with a yellowish tint, odorless or with a weak specific odor.

	1 g
Pyrithione zinc	2 mg

Excipients: macrogol cetostearyl ether – 12 mg, cetostearyl alcohol – 68 mg, liquid paraffin (mineral oil) – 200 mg, propylene glycol – 292.5 mg, dexpanthenol – 6 mg, sodium dihydrogen phosphate dihydrate – 0.4 mg, disodium hydrogen phosphate dodecahydrate – 1.5 mg, purified water – up to 1 g.

From 10 g to 200 g – tubes (1) – cardboard packs

Derma-Cap [Tula Pharmaceutical Factory, LLC (Russia)]
External use aerosol 0.2%: cans from 10 g to 200 g