(and dosage form):
Each 1g of cream contains:
Clotrimazole 10 mg
A: 20.2.2 Fungicides
A broad spectrum antimycotic with fungicidal properties.
Clomaderm cream indications are:
All dermatomycoses due to dermatophytes (e.g. Trichophyton species).
Dermatomycoses due to moulds and other fungi.
Skin diseases with secondary infection by these fungi.
The dermatomycoses mentioned under 1-3 include among others:
Mycoses of the skin and skin folds
Interdigital mycoses, e.g. athletes foot
Paronychias (associated with nail mycosis).
Possible hypersensitivity to clotrimazole.
DOSAGE AND DIRECTIONS FOR USE:
For external use only.
Apply thinly to the affected areas 2-3 times daily and rub in. Successful treatment demands that Clomaderm be applied correctly and over a sufficiently long period of time. The duration of treatment varies. In general, it is 3-4 weeks in the case of dermatomycoses due to dermatophytes: and approximately 3 week in Erythrasma and Pityriasis versicolor.
TREATMENT OF FUNGAL INFECTION SHOULD BE CONTINUED FOR APPROX. 2 WEEKS AFTER THE DISAPPEARANCE OF ALL SYMPTOMS DESPITE A RAPID, SUBJECTIVE IMPROVEMENT, IN ORDER TO PREVENT RELAPSE.
Athletes foot: Always dry the feet carefully, especially between the toes.
Clomaderm is odourless, can be washed off and does not stain.
Clomaderm is not indicated for ophthalmic use and should be used with caution around the eyes.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local reactions including irritation and burning may occur.
Contact allergic dermatitis can occur. If this occurs, treatment should be discontinued.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-Effects and Special Precautions. In case of accidental ingestion, gastro-intestinal disturbances and central nervous system depression may occur. Treatment is symptomatic and supportive.
A soft white cream.
Tube of 20 g
Store below 25ºC in a dry place.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
GULF DRUG COMPANY (PTY) LTD.
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
2 November 1993
New addition to this site: July 2010
Source: Pharmaceutical Industry
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