NIZORAL Shampoo Ref.[6933] Active ingredients: Ketoconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK

Therapeutic indications

Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff and seborrhoeic dermatitis. Treatment of tinea (pityriasis) versicolor.

Posology and method of administration

For topical administration.

Ketoconazole shampoo 2% is for use in adolescents and adults:

Wash affected areas and leave for 3-5 minutes before rinsing. Usually, a palmful of shampoo suffices for one wash.

Treatment

Dandruff and seborrhoeic dermatitis: Wash hair twice weekly for 2-4 weeks.

Tinea versicolor: Once daily for 1-5 days.

Prophylaxis

Dandruff and seborrhoeic dermatitis: Use once every 1-2 weeks.

Paediatric population

The safe and effective use of Nizoral 2% shampoo in infants and children under the age of 12 years has not been established.

Overdose

In the event of accidental ingestion, supportive and symptomatic measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.

Shelf life

36 months.

Special precautions for storage

Store below 25°C.

Nature and contents of container

High density polyethylene bottles, containing 120 ml shampoo.

Special precautions for disposal and other handling

No special requirements.

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