Dermazole shampoo 20 mg/ml bottle 50 ml

Dermazole Shampoo

Dermazole shampoo is used for the treatment and prevention of skin and hair conditions caused by Malassezia yeast (formerly Pityrosporum), such as dandruff, pityriasis versicolor (localized), and seborrheic dermatitis.

Composition

Active ingredient: ketoconazole (1 ml of shampoo contains 20 mg of ketoconazole).

Excipients: cocodiethanolamide, sodium laureth sulfate, disodium monolauryl ether sulfosuccinate, macrogol 120 methyl glucose dioleate, propylene glycol, concentrated hydrochloric acid, sodium chloride, sodium hydroxide, butylated hydroxytoluene (E 321), imidazolidinyl urea, Ponceau 4R (E 124), fragrance SK D00923, purified water.

Contraindications

Hypersensitivity to any component of the shampoo.

Method of Administration

Apply the shampoo to the affected areas for 3–5 minutes, then rinse with water.

Treatment:

• Dandruff and seborrheic dermatitis – 2 times a week for 2–4 weeks;
• Pityriasis versicolor – daily for 5 days.

Prevention:

• Dandruff and seborrheic dermatitis – weekly or once every two weeks;
• Pityriasis versicolor – daily for 3 days (single preventive course) before the summer season.

Special Precautions

Pregnancy: Adequate controlled studies in pregnant or breastfeeding women have not been conducted. After topical application, ketoconazole levels in plasma were not detectable. Since no known risks have been identified, use during pregnancy and breastfeeding is not contraindicated.

Children: Safety and efficacy in children under 12 years have not been established.

Drivers: Does not affect the ability to drive or operate machinery.

Overdose

As the product is intended for external use only, overdose is unlikely.

If accidentally swallowed, supportive and symptomatic treatment is recommended. Vomiting or gastric lavage should not be induced to avoid aspiration.

Side Effects

Immune system: hypersensitivity reactions, including angioedema and urticaria.

Skin and subcutaneous tissue: alopecia, dry skin, altered hair texture, rash, skin burning, acne, contact dermatitis, increased skin flaking, increased or decreased hair oiliness, hair discoloration (mainly in patients with chemically damaged or grey hair).

Eye disorders: increased tearing, eye irritation.

Nervous system: dysgeusia (taste disturbances).

Infections: folliculitis.

Storage Conditions

Store in the original package at a temperature not exceeding 25 °C, out of reach of children.

Shelf life: 4 years.