This information is intended for use by health professionals

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).

Excipients with known effects:

Ethanol 35.8 % w/w

Butylated hydroxytoluene (E321) 0.007% w/w

For the full list of excipients, see section 6.1.

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

Topical

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 different categories of patient.

4.3 Contraindications

Not recommended for nail or scalp infections.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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.

Contains butylated hydroxytoluene (E321). May cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

This medicine contains 35.8% w/w alcohol (ethanol). It may cause burning sensation on damaged skin.

Flammable, pressurised container. Protect from direct sunlight and do not expose to temperatures exceeding 50°C. 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

None stated.

4.6 Pregnancy and lactation

No known restrictions.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

Adverse reactions have been ranked under headings of frequency using the following convention:

Very common

≥ 1/10

Common

≥ 1/100 to ≥ 1/10

Uncommon

≥ 1/1,000 to < 1/100

Rare

≥ 1/10,000 to < 1/1,000

Very rare

<1/10,000

Within easy frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System Organ Class

Frequency

Skin and subcutaneous tissue disorder

Unknown

Skin reactions

Skin irritation

Pruritis

Contact dermatitis

4.9 Overdose

Not applicable.

5. Pharmacological properties
5.1 Pharmacodynamic properties

Antifungal

5.2 Pharmacokinetic properties

Not applicable for a topical dosage form.

5.3 Preclinical safety data

None stated

6. Pharmaceutical particulars
6.1 List of excipients

Butylated Hydroxytoluene (E321)

Polyethylene - polypropylene glycol monobutyl ether

Ethanol

Butane

Propane

Iso-butane

6.2 Incompatibilities

None stated.

6.3 Shelf life

48 months unopened.

6.4 Special precautions for storage

Warnings for the labelling:

Pressurised container: May burst if heated.

Keep away from heat/sparks/open flames/hot surfaces. – No smoking.

Do not spray on open flame or other ignition source.

Pressurised container: Do not pierce or burn, even after use.

Protect from sunlight. Do not expose to temperatures exceeding 50° C / 122° F.

Danger. Extremely Flammable Aerosol (and logo)

6.5 Nature and contents of container

Tinplate aerosol can, epoxy coated internally with valve assembly and overcap. Can sizes: 150ml.

6.6 Special precautions for disposal and other handling

None stated

7. Marketing authorisation holder

Scholl Consumer Products Ltd

103-105 Bath Road

Slough

SL1 3UH

UK

8. Marketing authorisation number(s)

PL 00587/0008

9. Date of first authorisation/renewal of the authorisation

24/04/85 / 29/01/99

10. Date of revision of the text

10/02/2021