Boots Dual Action Athletes Foot Powder
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Dual Action Athlete's Foot Powder
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient % w/w
Tolnaftate BP 1.0
Chlorhexidine Hydrochloride BP 0.25
3. PHARMACEUTICAL FORM
Topical powder.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Boots Dual Action Athlete's Foot Powder is indicated for the adjunctive treatment and prevention of Athlete's Foot (Tinea Pedis). It may also be helpful in conditions where tenderness and sweating cause skin irritation. 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
Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8)
4.4 Special warnings and precautions for use
Boots Dual Action Athlete's Foot Powder contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Boots Dual Action Athlete's Foot Powder should not be administered to anyone with a potential history of allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).
Keep all medicines out of the sight and reach of children.
For external use only.
If symptoms persist consult your doctor.
4.5 Interactions with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
4.6 Pregnancy and lactation
No special precautions necessary.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Skin disorders
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation and blisters.
Immune disorders
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
4.9 Overdose
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Tolnaftate is a well established drug substance having potent anti-fungal properties.
Chlorhexidine hydrochloride 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
Aerosil 200
Purified talc sterilised
Maize starch (low bacterial count)
6.2 Incompatibilities
None applicable.
6.3 Shelf life
36 months
6.4 Special precautions for storage
None
6.5 Nature and contents of container
Tin with polythene closure containing 55g.
Printed white plastic bottles with plastic plug and screw cap containing 55gm. Labelled pigmented plastic bottle with snap on plastic cap containing 75gm and 100gm.
6.6 Instructions for use/handling
None.
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
MARKETING AUTHORISATION NUMBER
8.
PL 0014/0456
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
13/12/2004
10 DATE OF REVISION OF THE TEXT
08/09/2014