Boots Dual Action Athlete's Foot Powder

1. Name Of The Medicinal Product

Boots Dual Action Athlete's Foot Powder

2. Qualitative And Quantitative Composition

Active ingredient	% w/w
Tolnaftate BP	1.0
Chlorhexidine Hydrochloride BP	0.25

3. Pharmaceutical Form

Topical powder.

4. Clinical Particulars

4.1 Therapeutic Indications

Boots Dual Action Athlete's Foot Powder is indicated 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).

For cutaneous use.

4.2 Posology And Method Of Administration

Adults, children and the elderly: The affected area should be treated morning and night. Treatment should continue for at least a week after the infection has cleared.

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.

If symptoms persist consult your doctor.

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 precautions necessary.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasionally may cause skin irritation, sensitivity and contact dermatitis.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Tolnaftate is a well established drug substance having potent anti-fungal 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 data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Aerosil 200

Purified talc sterilised

Maize starch (low bacterial count)

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Tin with polythene closure containing 55g.

Printed white plastic bottles with plastic plug and screw cap, containing 55gm.

Labelled pigmented plastic bottle with snap on plastic cap containing 75gm and 100gm.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 0014/0456

9. Date Of First Authorisation/Renewal Of The Authorisation

05 April 1994

10. Date Of Revision Of The Text

September 1999