Scholl Athlete’s Foot Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tolnaftate

Available from:

Scholl Consumer Products Limited

ATC code:

D01AE; D01AE18

INN (International Name):

Tolnaftate

Dosage:

1 percent weight/weight

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antifungals for topical use; tolnaftate

Authorization status:

Not marketed

Authorization date:

1986-11-19

Patient Information leaflet

Reckitt Benckiser
0003 PA 455/1/2 CCDS Update
Scholl Athletes Foot Powder 1% w/w
Page 1
ATHLETE’S FOOT CREAM
TOLNAFTATE 1% W/W
ANTI-FUNGUS
TREATS ATHLETE’S FOOT FUNGI
Read all of this leaflet carefully before you start using this
medicine because it contains
important information for you.
What is in this leaflet:
1. What Scholl Athlete’s Foot Cream is and what it is used for
2. What you need to know before you use Scholl Athlete’s Foot Cream
3. How to use Scholl Athlete’s Foot Cream
4. Possible Side Effects
5. How to store Scholl Athlete’s Foot Cream
6. Contents of the pack and other information
1. WHAT SCHOLL ATHLETE’S FOOT CREAM IS AND WHAT IT IS USED FOR
Scholl Athlete’s Foot Cream is a topical antifungal for the
treatment of Athlete’s Foot.
It contains Tolnaftate antifungal, an effective antifungal medication
available without
prescription for treating Athlete’s Foot Fungi.
2. BEFORE YOU USE SCHOLL ATHLETE’S FOOT CREAM
Do not use...
•
if you are allergic to Tolnaftate or any of the other ingredients of
this medicine listed in
Section 6
•
for nail and scalp infections
Warnings and Precautions:
Keep this leaflet - you may need to refer to it again.
This product contains: butylhydroxytoluene (E321), cetosteary alcohol
and chlorocresol
which may cause allergic reactions, local skin reactions (e.g. contact
dermatitis) or
irritation to the eyes and mucous membranes
3. HOW TO USE SCHOLL ATHLETE’S FOOT CREAM
Always use this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you. Check with your doctor or pharmacist if you
are not sure.
For External Use Only
•
Wash and dry infected area and apply liberally twice each day, or as
directed by a
doctor.
•
If seal on tube is broken do not use.
•
Wear clean socks or hosiery every day.
•
Continue for two weeks after symptoms disappear.
•
If symptoms do not improve within 10 days, stop use and speak to your
doctor.
4. POSSIBLE SIDE EFFECTS
1.3.1 Pa
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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Scholl Athlete’s Foot Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tolnaftate 1.00% w/w
Excipients: Butylated Hydroxytoluene (E321) 0.002% w/w
Chlorocresol 0.1% w/w
Cetostearyl alcohol 7.2% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Smooth, white, odourless cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a fungistat in the topical treatment of infections due to
dermatophytes sensitive to this agent including microspore,
epidermophyta and trichophyta.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
Adults: Apply to the affected area twice daily or as directed by a
doctor.
Continue treatment
for two weeks after symptoms disappear. Paediatric population: As
above for adults.
METHOD OF ADMINISTRATION:
Topical application only.
Wash and dry the infected before applying..
Wear clean socks or
hosiery.
Apply liberally.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in Section 6.1.
Contraindicated in nail or scalp infections.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
For external use only.
Keep out of eyes.
If irritation or rash continues, use of the product should be
discontinued and medical advice should be sought.
If symptoms do not improve within 10 days, discontinue use and consult
your doctor. Contains chlorocresol.
May
cause allergic reactions.
Also contains butylhydroxytolune (E321) and cetostearyl alcohol.
May cause local skin reactions (e.g. contact
dermatitis), or irritation to the eyes and muscos membranes.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Not applicable.
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