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Boots Dual Action Athlete's Foot Cream

Marketing Authorization Holder: The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

Authorised
Legal Category

General Sales List

ATC Code

Not classified

Authorization Number

PL0014/0457

Summary of Product Characteristics

Detailed prescribing information and pharmaceutical guidance from the UK Electronic Medicines Compendium.

Composition

Active and inactive ingredients

| | | | --- | --- | | **Active ingredient** | **Quantity** | | Tolnaftate BP | 1.0%w/w | | Benzalkonium chloride solution BP | 0.2%v/w | | **Excipients of known effect** | **Quantity** | | Cetostearyl alcohol | 6.0% w/w | See section 4.4 for further information. For a full list of excipients, see Section 6.1

Pharmaceutical Form

Dosage form and administration route

Cream

Clinical Particulars

Therapeutic indications and usage

4.1 Therapeutic indications Boots Dual Action Athlete's Foot Cream is indicated for the treatment and prevention of Athlete's Foot (Tinea Pedis). 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. 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 No clinically significant drug interactions known.4.6 Pregnancy and lactation No special requirements.4.7 Effects on ability to drive and use machines No adverse effects known.4.8 Undesirable effects Occasionally may cause skin irritation, hypersensitivity and contact dermatitis. ****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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard, or search Yellow Card in the Apple App or google Play Store.4.9 Overdose Not applicable.

Pharmacological Properties

Pharmacodynamics and pharmacokinetics

5.1 Pharmacodynamic properties Tolnaftate 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 data of relevance to the prescriber which are additional to that already included.

Pharmaceutical Particulars

Storage and handling information

6.1 List of excipients Arlatone 983S Cetostearyl alcohol Dimethicone 20 Liquid paraffin Glycerol Purified water6.2 Incompatibilities Not applicable.6.3 Shelf life 18 months6.4 Special precautions for storage Store in a cool place below 25°C.6.5 Nature and contents of container An internally lacquered metal tube with blind end nozzle. Tube to contain 25gm or 35gm.6.6 Special precautions for disposal and other handling None

Last updated: 30 September 2022

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