Mycil Ointment (Reckitt Benckiser Healthcare (UK) Ltd)

1. Name Of The Medicinal Product

Mycil Ointment.

2. Qualitative And Quantitative Composition

Tolnaftate BP 1.0% w/w

Benzalkonium Chloride Solution BP 0.2% v/w.

Excipients:

Cetostearly Alcohol

For a full list of excipients see 6.1.

3. Pharmaceutical Form

Ointment.

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 affected area before applying the ointment morning and night. Continue the treatment for at least a week after the infection has cleared up. Routine use of the ointment 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.

For external use only.

This product contains Cetostearyl Alcohol which may cause local skin reactions (e.g. contact dermatitis)

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

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

Benzalkonium chloride is a well established drug substance having potent anti-microbial 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

Arlatone 983s, cetostearyl alcohol, dimeticone 20, liquid paraffin, glycerol, purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store in a cool place.

6.5 Nature And Contents Of Container

Collapsible, internally lacquered metal tube with blind end nozzle containing 25g.

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 00063/0409

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 4 February 2009

10. Date Of Revision Of The Text

27/07/2011