Mycil Athlete’s Foot Spray

1. Name Of The Medicinal Product

Mycil Athlete's Foot Spray.

2. Qualitative And Quantitative Composition

Tolnaftate BP 0.12% w/w.

3. Pharmaceutical Form

Dry powder spray.

4. Clinical Particulars

4.1 Therapeutic Indications

For the adjunctive treatment and prevention of athlete's foot (Tinea Pedis).

It is also effective in other conditions, such as dhobie itch (Tinea Cruris) and prickly heat (Miliaria).

4.2 Posology And Method Of Administration

For topical application to the skin.

Wash and thoroughly dry the infected skin before use. Hold the can 15 cm from the skin then spray liberally morning and night. Continue the treatment for at least a week after the infection has cleared up. Routine use of the spray can help prevent infection.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Keep all medicines out of the reach of children.

Keep away from eyes.

For external use only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

No special requirements.

4.7 Effects On Ability To Drive And Use Machines

None.

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.

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

Talc, denatured ethanol B, bentone 38, dimethyl ether.

6.2 Incompatibilities

None known.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Internally lacquered aluminium can fitted with a continuous spray valve and an actuator.

Pack size 150gml.

6.6 Special Precautions For Disposal And Other Handling

Caution flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use. Do not spray on a naked flame. Do not use near, or place container on, polished or painted surfaces. CFC-free - does not contain CFCs which damage ozone.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited

Slough, SL1 4AQ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00063/0414

9. Date Of First Authorisation/Renewal Of The Authorisation

12^th November 2010

10. Date Of Revision Of The Text

12/01/2011