Skip to Content

BOOTS DUAL ACTION ATHLETES FOOT CREAM

Active substance(s): BENZALKONIUM CHLORIDE SOLUTION / TOLNAFTATE / BENZALKONIUM CHLORIDE SOLUTION / TOLNAFTATE

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Dual Action Athlete’s Foot Cream

2

3

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient

Quantity

Tolnaftate BP

l.0 % w/w

Benzalkonium chloride solution BP

0.2 % v/w

PHARMACEUTICAL FORM
Cream

4

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 our of the reach of children.
For external use only.
If symptoms persist consult your doctor.

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.

4.9

Overdose
Not applicable.

5

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 antimicrobial 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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Arlatone 983S
Cetostearyl alcohol
Dimethicone 20
Liquid paraffin
Glycerol
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
18 months

6.4

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
None

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0457

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
12 April 1994

10

DATE OF REVISION OF THE TEXT
04/06/2015

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide