Superdrug Athletes Foot Powder
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scholl Athletes Foot Powder Superdrug Athletes Foot Powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate 1.0%w/w
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for topical application
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prevention and treatment of Athlete’s Foot.
4.2 Posology and method of administration
Wash and dry infected area, and apply twice daily or as directed by your doctor. Dust feet liberally, especially between toes. For added protection dust on socks, hosiery and inside shoes. Continue treatment for two weeks after symptoms disappear.
4.3 Contraindications
Not recommended for 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
Keep out of the reach and sight of children
4.5 Interaction with other medicinal products and other forms of interaction
Not relevant to topical use
4.6 Pregnancy and lactation
No known restrictions.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
|
Adverse reactions have been ranked under headings of frequency 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 | |
|
Within easy frequency grouping, undesirable effects are presented in order of decreasing seriousness. | ||
|
System Organ Class |
Frequency | |
|
Skin and subcutaneous tissue disorder |
Unknown |
Skin reactions Skin irritation Pruritis Contact dermatitis |
4.9 Overdose
Not relevant to topical use.
PHARMACOLOGICAL PROPERTIES
5
5.1 Pharmacodynamic properties
Tolnaftate
Topical antifungal agent (ATC Classification: D01AE 18)
5.2 Pharmacokinetic properties
Not applicable for a topical dosage form of this type
5.3 Preclinical safety data
None stated
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Talc
Starch
6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months, unopened
Once opened, use within 6 months
6.4 Special precautions for storage
Store below 25°C.
6.5 Nature and contents of container
High density poly-ethylene container with sifter assembly. 75g of product
Special precautions for disposal
6.6
No special precautions required
7 MARKETING AUTHORISATION HOLDER
Scholl Consumer Products Ltd
103-105 Bath Road
Slough
SL1 3UH
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 00587/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/04/1985 / 12/01/2005
10 DATE OF REVISION OF THE TEXT
19/09/2016