Summary of Product Characteristics (SmPC) - Scholl Athletes 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).
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
Posology
Adults:
Recommended Dose: Twice daily, in the morning and at night.
Treatment should continue for up to two weeks after the symptoms disappear.
Paediatric population:
Children aged 2 years and over: As above for adults.
Children under 2 years old: Not recommended for children under 2 years unless advised by a health care professional.
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.
Wear clean socks or hosiery.
Apply liberally to the affected area.
4.3 Contraindications
Contraindicated in 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.
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.
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.
If irritation or rash occurs, use of the product should be discontinued and medical advice should be sought.
4.5 Interaction with other medicinal products and other forms of interaction
None stated.
4.6 Pregnancy and lactation
Pregnancy:
No effects during pregnancy are anticipated since systemic exposure to tolnaftate is negligible. Tolnaftate can be used during pregnancy.
Breast-feeding:
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding women to tolnaftate is negligible. Tolnaftate can be used during breast-feeding. Application onto the breast is not recommended during breast feeding.
Fertility:
No data on human fertility is available
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
Adverse reactions which have been associated with Tolnaftate have been ranked under headings of system organ class and frequency. Frequencies are defined 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
Not known (cannot be estimated from the available data)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Events |
| Skin and Subcutaneous Tissue Disorders | Not Known | Skin reaction, skin irritation, pruritus, dermatitis contact. |
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms:
There have been no reports of over dosage with the use of this product.
Management:
In the case of over dosage, treatment should be symptomatic and supportive.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Dermatologicals, Antifungals for Dermatological use, Antifungals for Topical use, Other Antifungals for Topical use.
ATC Classification: D01A E18
Tolnaftate is a topical antifungal agent
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 50º C / 122º 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
None stated
7 MARKETING AUTHORISATION HOLDER
Scholl’s Wellness Company Limited 1 Arlington Square,
Downshire Way,
Bracknell, Berkshire,
RG12 1WA,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 56058/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/04/85 / 29/01/99
10 DATE OF REVISION OF THE TEXT
25/07/2025