Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
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 Miconazole nitrate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
FONTS USED Interstate-LightCondensed
The name of your medicine is Daktarin 2% w/w cream. It is called Daktarin cream in this leaflet.
SMALLEST TEXT SIZE
8.00 pt AVE. TEXT SIZE
Daktarin cream contains a medicine called miconazole. This belongs to a group of medicines called 'antifungals'.
9 pt LARGEST TEXT SIZE
18.00 pt
Daktarin cream is used for infections of the skin or nails caused by fungi including yeasts, and some bacteria. Infections may appear on the:
e Daktarin cream Do not use Daktarin cream:
Warnings and precautions
1135
CHILD
Product / Eurocode / Mat. ID Code 7504704
PACKAGE LEAFLET: INFORMATION FOR THE USER
Keep this medicine away from your eyes. If you get any cream in your eyes, rinse with water straight away. Keep your eyes open when you rinse. If you are taking oral anticoagulant agents such as warfarin, stop using Daktarin Cream immediately and seek advice from your doctor or pharmacist if you experience unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit during treatment with Daktarin Cream. Close monitoring of International Normalized Ratio (INR) levels are required under the supervision of a healthcare professional during treatment with Daktarin Cream.
Other medicines and Daktarin Cream
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You may still be able to use Daktarin cream if your doctor thinks you need to.
Driving and using machines
Daktarin cream is not likely to affect you being able to drive or use any tools or machines.
Daktarin cream contains Benzoic Acid (E210) and Butylated hydroxyanisole (E320)
Daktarin cream Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Using the cream
For skin infections
For nail infections
Personal hygiene
If you swallow Daktarin cream
If you swallow any cream, talk to a doctor or go to the nearest hospital casualty department straight away.
If you forget to use Daktarin cream
4 Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Daktarin cream and tell your doctor straight away if you notice the following. You may need medical treatment.
Very rare (affects less than 1 in 10,000 people)
Tell your doctor or pharmacist if you notice any of the following side effects: Very rare (affects less than 1 in 10,000 people)
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Talk to your doctor, pharmacist or dentist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal medicines.
In particular tell your doctor if you are taking:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GB-IE – 786889
By reporting side effects you can help provide more information on the safety of this medicine.
Daktarin cream Keep this medicine 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 carton and tube. 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.
What Daktarin cream contains
The active substance is miconazole nitrate. Each gram (g) of Daktarin cream contains 20 milligrams (mg) of miconazole nitrate (2 % w/w). The other ingredients are water, PEG-6, PEG-32 and glycol stearate, oleoyl macroglycerides, liquid paraffin, benzoic acid (E210) and butylated hydroxyanisole (E320).
What Daktarin cream looks like and contents of the pack
Daktarin cream comes in a tube containing 30 g of a white cream Marketing Authorisation Holder: McNeil Products Limited, 50 – 100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK.
Manufacturer: Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium OR
McGregor Cory Ltd, Middleton Close, Banbury, OX16 4RS, UK
For information in large print, tape, CD or Braille, telephone 0800 7318450. This leaflet was last revised in September 2025.
Daktarin 2% w/w cream comes as cream. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Daktarin 2% w/w cream is miconazole nitrate.
Medicines with the same active substance, strength and form include: Daktarin 2% Cream, Daktarin Aktiv Cream. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Daktarin 2% w/w cream, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
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.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of mycotic infections of the skin and nails and superinfections due to Gram-positive bacteria.
Route of administration:
Cutaneous use.
Recommended dosage:
For all ages:
Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. If the powder is used with the cream, a once daily application of both formulations is recommended. The duration of therapy varies from 2 to 6 weeks depending on the localisation and the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms.
Nail infections: Apply the cream once or twice daily to the lesions. Treatment should be prolonged for 10 days after all lesions have disappeared to prevent relapse.
Daktarin 2%w/w cream is contraindicated in individuals with a known hypersensitivity to miconazole/miconazole nitrate, other imidazole derivatives or to any of the excipients listed in section 6.1.
Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Cream and with other miconazole topical formulations (see section 4.8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Daktarin 2% w/w cream must not come into contact with the mucosa of the eyes.
Excipients:
This medicine contains 2 mg benzoic acid in each gram of cream. Benzoic acid may cause local irritation and may increase jaundice in new-born babies (up to 4 weeks old).
Butylated hydroxyanisole: May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Miconazole administered systemically is known to inhibit CYP3A4/2C9, which can lead to prolonged effects of warfarin or other vitamin K antagonists. While systemic absorption is limited with topical formulations, the concomitant use of Daktarin 2% w/w Cream and warfarin or other vitamin K antagonists should be done with caution and the anticoagulant effect should be carefully monitored and titrated. Patients should be advised of the symptoms of bleeding events and to immediately stop treatment with miconazole and seek medical advice should they occur (see section 4.5).
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on warfarin or other vitamin K antagonists, caution should be exercised and anticoagulant effect should be monitored.
Pregnancy
In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy.
Lactation
Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation.
Not applicable.
Adverse reactions reported among 426 patients who received miconazole 2% cream base in 21 double-blind clinical trials are presented in Table A below.
Based on pooled safety data from these clinical trials, the most commonly reported adverse reaction was Application site irritation (0.7%).
Including the above-mentioned adverse reaction,
Table A displays adverse reactions that have been reported with the use of topical, non-gynaecological, miconazole nitrate/miconazole 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); and very rare (< 1/10,000, including isolated reports) and Not Known (cannot be estimated from the available data).
Table A: Adverse Reactions Reported in Clinical Trials and Post-marketing Experience
System Organ Class
Adverse Reactions
Frequency Category
Uncommon
(≥1/1,000 to <1/100)
Not Known
Immune System Disorders
Anaphylactic reaction
Hypersensitivity
Skin and Subcutaneous Tissue Disorders
Skin burning sensation
Skin inflammation
Angioedema
Urticaria
Contact dermatitis
Rash
Erythema
Pruritus
General Disorders and Administration Site Conditions
Application site reactions (including application site irritation, burning, pruritus, reaction NOS and warmth)
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Cutaneous use: Excessive use can result in skin irritation, which usually disappears after discontinuation of therapy.
Accidental ingestion: Stomach irritation may occur.
Treatment
Daktarin 2% w/w cream is intended for cutaneous use, not for oral use. If accidental ingestion of large quantities of the product occurs, use appropriate supportive care.
Ask anything about Daktarin 2% w/w 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.
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