Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Nizoral 2% Cream
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Ketoconazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for The name of your medicine is Nizoral 2% cream. It is called 'Nizoral cream' or just 'cream' in this leaflet. Nizoral cream contains a medicine called ketoconazole. This belongs to a group of medicines called 'antifungals'.
Nizoral cream is used for fungal and yeast infections of the skin in adults. Infections may appear on the:
- Trunk, chest or back
- Hands or feet
- Scalp or face
- Groin or genitals Nizoral cream works by killing the fungus that causes the infection.
What you need to know before you take it
e Nizoral cream Do not use Nizoral cream:
- If you are allergic to anything in Nizoral cream (listed in section 6 below)
- For eye infections Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before using Nizoral cream.
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine:
- If you have recently used a cream, ointment or lotion on your skin infection that contains a steroid:
- You should continue to apply a mild steroid (such as hydrocortisone) cream, ointment or lotion in the morning whilst applying Nizoral cream in the evening. The mild steroid treatment can then be gradually stopped over a period of 2-3 weeks. If you have any questions about stopping your steroid cream, ointment or lotion, ask your doctor or pharmacist.
Children and adolescents
Nizoral Cream is not recommended for use in children under 18 years of age.
Other medicines and Nizoral Cream
Nizoral cream does not normally react with other medicines. However, tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
Pregnancy and breast-feeding
Nizoral cream can be used if you are pregnant or breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Nizoral cream is not likely to affect you being able to drive or use any tools or machines.
Nizoral cream contains propylene glycol
This medicine contains 6000 mg propylene glycol in each 30 g tube, which is equivalent to 200 mg/g.
Nizoral cream contains cetyl alcohol and stearyl alcohol
Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
How to take it
Nizoral cream Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How often you should use Nizoral cream Your doctor will tell you how often to use Nizoral cream and for how long.
The recommended dose is:
- For skin infections of the trunk, groin, feet and hands, apply Nizoral cream to the affected and immediate surrounding area once or twice a day. Your doctor will tell you how often to use it and for how long.
- For skin infections with reddish brown patches and yellow or white scaling (seborrheic dermatitis), apply Nizoral Cream once or twice a day. Skin infections will usually get better after 2 to 4 weeks.
Personal hygiene
- Unless the affected skin is on your hands, wash your hands with soap and water after using the cream
- Washing your hands after using the cream will stop you spreading the infection to other parts of your body or to other people
- Do not allow other people to use your flannel or towel. This will stop them from getting your infection
- Clothing that touches infected skin should be washed and changed often. Nizoral cream is non-greasy and should not stain clothes
If you stop using Nizoral cream
Usually you will see signs of improvement after 4 weeks. If this is not the case, talk to your doctor. Keep on using the cream until a few days after all symptoms have completely disappeared.
Your doctor will tell you how often to use Nizoral cream and for how long. Do not use the cream more often than your doctor has told you. Depending on the type of infection, treatment may last 2 to 6 weeks.
Even after your skin is completely cured, you sometimes have to apply the cream once weekly or once per 2 weeks. This prevents your symptoms from recurring.
Preparing your skin
If you swallow Nizoral cream
- Wash the infected skin and dry it well
Using Nizoral cream
- Each tube of Nizoral cream is sealed. You will need to use the cap to pierce the seal
- Rub the cream gently into the affected area and surrounding skin with clean fingers
- Do not put Nizoral cream in the eyes
If you swallow any cream, tell your doctor straight away.
If you use Nizoral cream more often than you should If you use Nizoral cream more often than you should, it may cause some burning sensation, redness or swelling. If this occurs, stop using Nizoral cream straight away.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Nizoral cream and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.
- Severe irritation or reddening of the skin where the cream has been used, or other signs of allergy during the first few days of treatment. This can affect fewer than 1 in 10 people
- Peeling or blistering of the skin. This can affect fewer than 1 in 100 people
Tell your doctor or pharmacist if you notice or suspect any of the following side effects: Common side effects (affects fewer than 1 in 10 people)
- Burning sensation
Uncommon side effects (affects fewer than 1 in 100 people)
- Problems where the cream has been used such as:
- Bleeding
- Discomfort
- Dryness
- Inflammation (contact dermatitis)
- Tingling
- Rash, hives (also known as nettle rash or urticaria)
- Sticky skin
Reporting of side-effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Nizoral cream Keep out of the sight and reach of children.
Store the cream in its original packaging. Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Nizoral Cream contains
The active substance is ketoconazole. Each gram (g) of cream contains 20 milligrams (mg) of ketoconazole (2 % w/w).
The other ingredients are purified water, propylene glycol, cetyl alcohol, stearyl alcohol, sorbitan stearate, polysorbate 60, polysorbate 80, sodium sulphite (E221) and isopropyl myristate. See section 2 'Nizoral Cream contains' for further information.
What Nizoral cream looks like and contents of the pack
Nizoral cream comes in a tube containing 30 g of white cream. Product license holder and Manufacturer: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK.
For information in large print, tape, CD or Braille, telephone 01484 848164. This leaflet was last revised in October 2023.
1370873 9354100 2309 GB
Frequently asked questions about Nizoral 2% Cream
How do I take Nizoral 2% Cream?
Nizoral 2% Cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Nizoral 2% Cream?
The active substance in Nizoral 2% Cream is ketoconazole.
Are there equivalent medicines to Nizoral 2% Cream?
Medicines with the same active substance, strength and form include: Daktarin Gold 2% Cream, Daktarin Intensiv Cream. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Nizoral 2% Cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Nizoral 2% Cream without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: ketoconazole
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
For topical application in the treatment of dermatophyte infections of the skin such as tinea corporis, tinea cruris, tinea manus and tinea pedis infections due to Trichophyton spp, Microsporon spp and Epidermophyton spp. Nizoral 2% cream is also indicated for the treatment of cutaneous candidosis (including vulvitis), tinea (pityriasis) versicolor and seborrhoeic dermatitis caused by Malassezia (previously called Pityrosporum) spp.
4.2. Posology and method of administration
Ketoconazole cream is for use in adults.
Cutaneous candidosis, tinea corporis, tinea cruris, tinea manus, tinea pedis and tinea (pityriasis) versicolor:
It is recommended that Nizoral 2% cream be applied once or twice daily to cover the affected and immediate surrounding area.
The usual duration of treatment is: tinea versicolor 2–3 weeks, yeast infections 2-3 weeks, tinea cruris 2-4 weeks, tinea corporis 3–4 weeks, tinea pedis 4-6 weeks.
Seborrheic dermatitis:
Nizoral 2% cream should be applied to the affected areas once or twice daily.
The usual initial duration of treatment in seborrheic dermatitis is 2 to 4 weeks. Maintenance therapy can be applied intermittently (once weekly) in seborrheic dermatitis.
Treatment should be continued until a few days after the disappearance of all symptoms. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment. General measures in regard to hygiene should be observed to control sources of infection or reinfection.
Seborrhoeic dermatitis is a chronic condition and relapse is highly likely.
Method of administration: Cutaneous administration.
Paediatrics patients
The safety and efficacy of Nizoral 2% cream in children (17 years of age and younger) has not been established.
4.3. Contraindications
Nizoral 2% cream is contra-indicated in patients with a known hypersensitivity to any of the ingredients or to ketoconazole itself.
4.4. Special warnings and precautions for use
Nizoral 2% cream is not for ophthalmic use.
If coadministered with a topical corticosteroid, to prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids it is recommended to continue applying a mild topical corticosteroid in the morning and to apply Nizoral 2% cream in the evening, and to subsequently and gradually withdraw the topical corticosteroid therapy over a period of 2-3 weeks.
Nizoral cream contains 6000 mg propylene glycol in each 30 g tube, which is equivalent to 200 mg/g.
Nizoral cream contains cetyl alcohol and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole.
Plasma concentrations of ketoconazole are not detectable after topical application of Nizoral 2% Cream to the skin of non-pregnant humans. (See Pharmacokinetic properties, section 5.2) There are no known risks associated with the use of Nizoral 2% Cream in pregnancy or lactation.
4.7. Effects on ability to drive and use machines
Nizoral 2% cream has no influence on the ability to drive and use machines.
4.8. Undesirable effects
The safety of ketoconazole cream was evaluated in 1079 subjects who participated in 30 clinical trials. Ketoconazole cream was applied topically to the skin. Based on pooled safety data from these clinical trials, the most commonly reported (≥1% incidence) adverse reactions were (with % incidence): application site pruritus (2%), skin burning sensation (1.9%), and application site erythema (1%).
Including the above-mentioned adverse reactions, the following table displays adverse reactions that have been reported with the use of ketoconazole cream from either clinical trial or postmarketing experiences. The displayed frequency categories use the following convention:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not Known (cannot be estimated from the available clinical trial data).
System Organ Class
Adverse Reactions
Frequency Category
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1,000 to <1/100)
Not Known
Immune System Disorders
Hypersensitivity
Skin and Subcutaneous Tissue Disorders
Skin burning sensation
Bullous eruption
Dermatitis contact
Rash
Skin exfoliation
Sticky skin
Urticaria
General Disorders and Administration Site Conditions
Application site erythema
Application site pruritus
Application site bleeding
Application site discomfort
Application site dryness
Application site inflammation
Application site irritation
Application site paresthesia
Application site reaction
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:
Yellow Card Scheme
Website: https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Topical Application
Excessive topical application may lead to erythema, oedema and a burning sensation, which will disappear upon discontinuation of the treatment.
Ingestion
In the event of accidental ingestion, supportive and symptomatic measures should be carried out.
💬 Ask about this leaflet
Ask anything about Nizoral 2% Cream. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.