Nizoral Antifungal Shampoo for Dandruff and Seborrheic Dermatitis 60 ml

Nizoral Antifungal Shampoo for Dandruff and Seborrheic Dermatitis 60 ml

Composition:

1 g of shampoo contains:
Ketoconazole — 20 mg/g (2%).
Excipients: 
Sodium laureth sulfate, disodium laureth sulfosuccinate, coconut fatty acid diethanolamide, hydrolyzed collagen, macrogol-120-methyl glucose dioleate, sodium chloride, sodium hydroxide, concentrated hydrochloric acid, imidurea, fragrance, purified water.

Product Description:

Specialized broad-spectrum antifungal shampoo for the treatment and prevention of scalp and hair conditions.
Ketoconazole exerts a pronounced antifungal effect by inhibiting ergosterol synthesis and disrupting the cell membrane integrity of fungi and yeasts.
Targeted at eliminating the root cause of dandruff and seborrheic dermatitis, it rapidly relieves inflammation, redness, irritation, and itching of the scalp, while preventing recurrence of flaking when used regularly for prevention.

Indications for Use:

Treatment and prevention of seborrheic dermatitis and dandruff of various origins.
Pityriasis versicolor (tinea versicolor).
Scalp psoriasis (as part of combination therapy).

Method of Administration and Dosage:

• Method of Administration: For external use only.
  Thoroughly wet hair and scalp with water, apply a small amount of shampoo, and massage into a rich lather.
• Exposure Time: Leave the lather on the scalp for 3–5 minutes before rinsing to achieve maximum therapeutic effect, then rinse thoroughly with water.
• Treatment Regimen:
  Dandruff and Seborrheic Dermatitis Treatment: Apply twice weekly for 2–4 weeks.
• Prevention: Apply once every 1–2 weeks to prevent recurrence.
• Age Restrictions: Suitable for adults and adolescents over 12 years of age.

Contraindications:

Hypersensitivity to ketoconazole or any of the excipients in the formulation.
Children under 12 years of age (safety and efficacy have not been established).

Precautions:

• External Use Only: Avoid contact with eyes and oral ingestion.
• Eye Contact: In case of contact with eyes, rinse immediately with plenty of clean water.
• Irritation: Discontinue use if severe local irritation or individual allergic reaction occurs.
• Systemic Corticosteroids: When transitioning from prolonged treatment with topical corticosteroids, to avoid withdrawal syndrome, it is recommended to continue their application alongside the shampoo, followed by gradual withdrawal of the steroid over 2–3 weeks.

Adverse Reactions / Side Effects:

Local Reactions: Rare local irritation, dryness or oiliness of the scalp and hair, mild itching, burning sensation, erythema.
Hair Reactions: Altered hair texture; in rare cases, hair discoloration (primarily in patients with chemically treated or gray hair).

Pregnancy and Lactation:

Ketoconazole is minimally absorbed into systemic circulation upon topical application; therefore, use during pregnancy is permitted as prescribed by a physician.
Permitted for use during breastfeeding (avoid application to the breast area).

Storage Conditions:

Store in a dry, light-protected place at a temperature not exceeding +30 °C.
Keep out of reach of children.

Packaging:

60 ml plastic bottle in a protective cardboard box with an instruction leaflet.