Mycil Powder (Reckitt Benckiser Healthcare (UK) Ltd)

1. Name Of The Medicinal Product

Mycil Powder.

2. Qualitative And Quantitative Composition

Tolnaftate BP 1.0% w/w

Chlorhexidine hydrochloride BP 0.25% w/w.

3. Pharmaceutical Form

Powder.

4. Clinical Particulars

4.1 Therapeutic Indications

For the adjunctive treatment and prevention of athlete's foot (Tinea Pedis). It may also be helpful in conditions where tenderness and sweating cause skin irritation. It is also effective in other conditions, such as dhobie itch (Tinea Cruris) and prickly heat (Miliaria) and tenderness due to excessive perspiration.

4.2 Posology And Method Of Administration

For topical application to the skin.

Wash and thoroughly dry the affected area before applying the powder liberally morning and night. Continue the treatment for at least a week after the infection has cleared up.

4.3 Contraindications

None known.

4.4 Special Warnings And Precautions For Use

None known.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

No special precautions necessary.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

None known.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Tolnaftate is a well established drug substance having potent antifungal properties.

Chlorhexidine hydrochloride is a well established drug substance having potent antimicrobial properties.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Aerosil 200,

Purified talc,

Maize starch.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

Tins with polythene closures or printed white or blue plastic bottles with plastic plug and screw cap containing 55g.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Dansom Lane

Hull

HU8 7DS

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0408

9. Date Of First Authorisation/Renewal Of The Authorisation

27.02.1991 / 30.03.2009

10. Date Of Revision Of The Text

30/03/2009