- Approval Id
- 77e26cf2a273d2d8
- Drug Approval Emc Name
- Boots Dual Action Athlete's Foot Cream
- Drug Name
- Boots Dual Action Athlete's Foot Cream
- Company Address
- 1 Thane Road West, Beeston, Nottingham, NG2 3AA
- Company Telephone
- +44 (0)1159 595 165
- Legal Category
- General Sales List
- Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Authorisation Number
- PL0014/0457
- Authorisation Date
- 12 April 1994
- Instruction Authorisation Holder
- The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
- Instruction Authorisation Number
- PL0014/0457
- Instruction Authorisation Date
- 12 April 1994
- Instruction Composition
- | | |
| --- | --- |
| \*\*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
- Instruction Dosage Form
- Cream
- Instruction Clinical Particulars
- 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.
- Instruction Pharmacology
- 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.
- Instruction Pharmaceutical Particulars
- 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
- Instruction Content
- ## Composition
| | |
| --- | --- |
| \*\*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
Cream
## Clinical Particulars
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
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
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
- Company Detail Path
- /organization/the-boots-company-plc
