Introduction About DENZOLE GEL

DENZOLE GEL contains Ketoconazole which belongs to the group of medicines called Antifungals. It is used in adults and children (12 years and older) with a normal immune system to manage seborrheic dermatitis (dry, flaky skin on the scalp, face, ears, chest, or upper back).

Ketoconazole works by inhibiting skin yeast colonization, reducing itching and redness, loosening the crusts and scales, and reduction of inflammation.

Before applying DENZOLE GEL inform your doctor if you have any skin problems or allergies. DENZOLE GEL should be used in pregnant and breastfeeding women only if considered necessary by your doctor. DENZOLE GEL has not been studied in children younger than 12 years of age so, consult your child’s doctor for advice.

The most common side effect is a burning feeling when DENZOLE GEL is applied. If any of the symptoms worsen, contact your doctor.

Uses Of DENZOLE GEL

• Manage seborrheic dermatitis

How DENZOLE GEL Works

DENZOLE GEL works by inhibiting skin yeast colonization, reducing itching and redness, loosening the crusts and scales, and reduction of inflammation.

How to use DENZOLE GEL

Apply DENZOLE GEL as advised by your physician. It is for external use only. Wash your hands before and after using DENZOLE GEL. Spread a thin layer evenly on the affected skin with your fingertips and cover all affected areas. Do not wash the areas where you applied DENZOLE GEL for at least 3 hours after applying it.

Wait at least 20 minutes after you use DENZOLE GEL on your skin before you put makeup or sunscreens on the affected areas. Use it only for the quantity and duration (preferably 2 weeks) specified by your doctor. Your physician will decide the correct dose and duration for you according to your age, body weight and disease condition.

Side Effects Of DENZOLE GEL

How To Manage Side Effects

Skin rash:

Avoid hot showers because hot water can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if your skin rash persists.

Warning & Precautions

Pregnancy

DENZOLE GEL should be used in pregnant women only if considered necessary. Consult your doctor before applying it.

Breastfeeding

DENZOLE GEL should be used in breastfeeding women only if considered necessary. If used during breastfeeding and the medicine is applied on the chest, take caution to avoid accidental ingestion of the medicine by your baby. Consult your doctor before applying it.

Allergy

Do not use DENZOLE GEL if you are allergic to Ketoconazole or any of the other ingredients of this medicine.

Interactions

A. Drug - Drug interactions:

Before applying DENZOLE GEL, inform your doctor if you are using, have used, or might use any other medicine, including prescription, non-prescription or any herbal medicine.

Overdosage:

If you or anyone else accidentally use too much of DENZOLE GEL, consult your doctor immediately or visit the nearby hospital.

Synopsis

More Information

• Keep DENZOLE GEL out of reach of children
• Store between 15-30°C

FAQs About DENZOLE GEL

What should I tell my doctor before using DENZOLE GEL?

Before using DENZOLE GEL, tell your doctor about all of your medical conditions, medications, allergies, or if you are pregnant or breastfeeding. Call your doctor if you experience anything unusual.

Can DENZOLE GEL be used during breastfeeding?

DENZOLE GEL should be used in breastfeeding women only if considered necessary by your doctor. If used during breastfeeding and the medicine is applied on the chest, take caution to avoid accidental ingestion of the medicine by your baby. Consult your doctor before using it.

Can DENZOLE GEL be used to manage fungal infections?

It is not known whether DENZOLE GEL can be used to manage fungal infections. It should not be used for any other condition other than prescribed for. Consult your doctor for further doubts.

What should I avoid while using DENZOLE GEL?

DENZOLE GEL is only to be used on the skin; avoid the eye, mouth, or vagina. This medicine is flammable so stay away from heat, flame, or smoking while you are applying it. Do not touch your eyes, nose, or mouth while you are applying DENZOLE GEL. Wash your hands well after you apply it as irritation may occur if you get it in your eyes, nose, or mouth.

Can DENZOLE GEL be used in children?

DENZOLE GEL has not been studied for use in children younger than 12 years of age. Consult your child’s doctor for advice. The doctor will choose an appropriate dose or select a suitable alternative management for your child.

References

1. KD. Tripathi. Antifungal Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 791, 792.

2. Thomas Berk and Noah Scheinfeld. Seborrheic Dermatitis. NIH National Library of Medicine, National center for biotechnology information. PubMed Central. June 2010. [Accessed 17th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2888552/

3. Hadeer Sinawe, Damian Casadesus. Ketoconazole. NIH National Library of Medicine. National Centre for Biotechnology Information. StatPearls [Internet]. June 2022. [Accessed 17th October 2022] https://www.ncbi.nlm.nih.gov/books/NBK559221/

4. Almirall, LLC. U.S. Food & Drug Administration. [Revised in December 2019] [Accessed 17th October 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021946s007lbl.pdf

5. Almirall, LLC. Ketoconazole gel. Dailymed. [Revised in August 2021] [Accessed 17th October 2022] https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=855e42bb-b57f-4772-bffa-d766ddcc46ce

Useful Diagnostic Tests

• Microscopic examination of the skin