Scholl Athlete's Foot Spray Liquid

1. Name Of The Medicinal Product

Scholl Athlete's Foot Spray Liquid.

2. Qualitative And Quantitative Composition

Tolnaftate 0.068% w/w (to deliver 1% to the skin).

3. Pharmaceutical Form

Topical spray.

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention and treatment of Athlete's Foot.

4.2 Posology And Method Of Administration

Adults and children: For best results, the feet should be washed and dried before use. Shake can before use. Point nozzle towards the affected area, holding it 10-15cm away. Spray liberally over the affected area. Recommended dose: Twice daily; in the morning and at night. Treatment should continue for up to two weeks after the symptoms disappear. No distinction is made between the different categories of patient.

4.3 Contraindications

Not recommended for nail or scalp infections.

4.4 Special Warnings And Precautions For Use

For external use only. Keep out of eyes. If symptoms do not improve within 10 days, discontinue use and consult your doctor. Keep out of the reach of children. Flammable, pressurised container. Protect from direct sunlight and do not expose to temperatures exceeding 50^oC. Do not spray on naked flame or incandescent material. Do not pierce or burn even after use.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Not applicable.

4.6 Pregnancy And Lactation

No known restrictions.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

None stated.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Antifungal.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Butylated Hydroxytoluene BP; Polyethylene – propylene glycol monobutyl ether; Ethanol BP; Butane.

6.2 Incompatibilities

Not relevant.

6.3 Shelf Life

Four years (48 months).

6.4 Special Precautions For Storage

Keep out of reach of children. Flammable, pressurised container. Protect from direct sunlight and do not expose to temperatures exceeding 50^oC.

6.5 Nature And Contents Of Container

Tin plate aerosol can, epoxy coated internally with valve assembly and overcap. 150ml.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Scholl Consumer Products Limited, Venus, 1 Old Park Lane, Trafford Park, Manchester

M41 7HA

8. Marketing Authorisation Number(S)

PL 0587/0008.

9. Date Of First Authorisation/Renewal Of The Authorisation

24^th April 1985/30^th June 2004

10. Date Of Revision Of The Text

June 2006