NOTICE
ANSM - Updated on : 20/05/2025
Drug name
DAKTARIN 2%, powder for cutaneous application
Miconazole nitrate
Sidebar
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information provided in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is DAKTARIN 2%, powder for cutaneous application and what is it used for?
2. What do I need to know before using DAKTARIN 2%, powder for cutaneous application?
3. How do I use DAKTARIN 2%, powder for cutaneous application?
4. What are the possible side effects?
5. How to store DAKTARIN 2%, powder for cutaneous application?
6. Package contents and other information.
1. WHAT IS DAKTARIN 2%, powder for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: TOPICAL ANTIFUNGAL - IMIDAZOLATED AND TRIAZOLATED DERIVATIVES, ATC code: D01AC02.
Daktarin powder is indicated for the treatment of skin infections between the fingers or toes or in the wool folds caused by fungi, including yeasts.
In the case of groin fold infections, oral antifungal treatment is required to treat a possible digestive and/or vaginal source, and thus avoid any recurrence.
2. WHAT DO I HAVE TO KNOW BEFORE USING DAKTARIN 2%, powder for cutaneous application?
Never use DAKTARIN 2%, powder for cutaneous application:
- if you are allergic to the active substance, to other similar antifungal medicines or to any of the other components of this medicine, as listed in section 6.
Warnings and precautions
DAKTARIN 2%, powder for cutaneous application may cause severe allergic reactions. You should be aware of the signs of an allergic reaction when taking DAKTARIN 2%, powder for cutaneous application (see Adverse reactions).
- Avoid contact with eyes.
- It is recommended not to use soaps with an acid pH (acidity favors candida multiplication).
- Wash the affected area and dry thoroughly.
- Gently spread the powder with your fingertips.
- Don't just treat the damaged skin, apply the powder around the infected area too.
- When applying to children, over a large area or to injured skin, it is essential to follow the recommendations and dosage indicated by your doctor, as the drug penetrates more deeply in these circumstances.
- Wash your hands thoroughly after using this product, unless you are using the hand treatment.
- Make sure you regularly change any clothing in contact with the infected area to avoid recontamination.
- Keep a towel and washcloth for personal use, to avoid infecting others.
- Foot infection: put powder in your socks and shoes once a day to treat foot infection.
- Avoid inhaling DAKTARIN 2%, powder for cutaneous application. This medicine contains talcum powder, which may cause respiratory problems. Apply powder close to the body to avoid inhalation. For treatment of infants and children, carefully shake the powder in the baby's diaper or in your hands and apply to infected areas.
- Keep bottle out of reach of children.
Ask your doctor or pharmacist before using DAKTARIN 2%, powder for cutaneous application.
Children
Not applicable.
Other drugs and DAKTARIN 2%, powder for cutaneous application
Not applicable.
DAKTARIN 2%, powder for cutaneous application with food and drink
Not applicable.
Pregnancy and breast-feeding
Pregnancy
Miconazole nitrate may be used during pregnancy at any stage.
Lactation
No effect on the newborn/breast-fed infant is expected due to the negligible systemic exposure of breast-feeding women to miconazole by the cutaneous route.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this product.
Driving and use of machinery
Not applicable.
DAKTARIN 2%, powder for cutaneous application contains {name excipient(s)}
Not applicable.
3. HOW DO I USE DAKTARIN 2%, powder for cutaneous application?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
For cutaneous use.
Dosage
Powder the affected areas and their periphery twice a day, after cleansing and drying the skin. Follow with a gentle, regular massage.
Method and route of administration
Wash your hands thoroughly after applying this product and after any contact with affected areas. This is particularly important to avoid spreading the fungus to other parts of the body or to other people.
Duration of treatment
The duration of treatment is 2 to 4 weeks, depending on the mycosis, and may be longer for certain localizations. Do not stop taking the drug for at least a week after symptoms have disappeared. Regular use of this medication throughout the treatment period is crucial to its success.
If you have used more DAKTARIN 2%, powder for cutaneous application than you should have
Accidental ingestion of a small quantity of DAKTARIN 2%, powder for cutaneous application is normally harmless. However, call your doctor to be sure there is no problem.
Accidental inhalation of large quantities of DAKTARIN 2%, powder for dermal application may cause breathing problems. If this happens, seek medical attention immediately.
If you forget to use DAKTARIN 2%, powder for cutaneous application
Not applicable.
If you stop using DAKTARIN 2%, powder for cutaneous application
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone:
- itching, irritation at the application site, burning sensation of the skin, redness of the skin, swelling of the face (see Severe allergic reactions).
Severe allergic reactions have been reported with DAKTARIN 2%, powder for cutaneous application. Signs of a severe allergic reaction may include :
- swelling of the face, lips, mouth, tongue or throat,
- difficulty swallowing or breathing,
- an itchy rash (urticaria).
You should stop taking DAKTARIN 2%, powder for cutaneous application and consult a doctor immediately if you notice or suspect any of these side effects.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW DO I USE DAKTARIN 2%, powder for cutaneous application?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box. The expiration date refers to the last day of that month.
Store at temperatures below 25°C.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What DAKTARIN 2%, powder for cutaneous application, contains
- The active substance is :
Miconazole nitrate.................................................................................................................. 2 g
For 100 g of powder for cutaneous application.
- Other components are :
Hydrophobic silica (Aerosil R 972), zinc oxide, talc.
What DAKTARIN 2%, powder for cutaneous application is and what it contains
This medicine comes in the form of a powder for cutaneous application.
30 g powder bottle, box of 1.
Marketing authorization holder
KENVUE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Marketing authorization holder
KENVUE FRANCE
43 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Manufacturer
LUSOMEDICAMENTA SOCIEDADE TÉCNICA FARMACÊUTICA S.A.
ESTRADA CONSIGLIERI PEDROSO 69-B QUELUZ DE BAIXO
2730-055 BARCARENA
PORTUGAL
Drug names in member states of the European Economic Area
Not applicable.
This leaflet was last revised on :
[to be completed later by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.