Patient leaflet - EURAX CREAM, EURAX ITCH RELIEF CREAM
PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1. NAME OF THE MEDICINAL PRODUCT
Eurax Itch Relief Cream
-
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Active ingredient Crotamiton
3. LIST OF EXCIPIENTS
Other ingredients Methyl hydroxybenzoate E218, phenylethyl alcohol, glycerol, triethanolamine, sodium lauryl sulphate, ethylene glycol monostearate, stearyl alcohol, strong ammonia solution, stearic acid, hard paraffin, white beeswax, purified water and Perfume (Contains: geraniol, citronellol, coumarin, benzyl alcohol (0.0187%), benzyl benzoate (0.0047%), citral, d-limonene, eugenol, linalool).
4. PHARMACEUTICAL FORM AND CONTENTS
Cream
30g , 100g
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Directions : Apply to the affected area 2–3 times daily. Irritation will be relieved for 6 to 10 hours. If symptoms persist consult your doctor. Eurax Itch Relief Cream can be used for children. For children under 3 years of age consult your doctor before use and do not apply more than once a day.
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6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Keep all medicines out of the sight and reach of children.
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7. OTHER SPECIAL WARNING(S), IF NECESSARY
Do not use:
In or around the eyes, on broken skin, for weeping skin conditions or if you are sensitive to any of the ingredients.
Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Cautions:
Eurax Itch Relief Cream is not recommended in pregnancy. Consult your doctor or pharmacist before using Eurax Itch Relief Cream if you are breast feeding or suffering from genital itching.
This medicine contains stearyl alcohol, methyl hydroxybenzoate which may cause allergic reactions /skin reactions e.g. contact dermatitis (possibly delayed) and perfume (including potential allergens benzyl alcohol (0.0187%), benzyl benzoate (0.0047%), citral, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool) which may cause allergic reactions. This medicine also contains 0.45% w/w sodium lauryl sulphate in each application. Sodium lauryl sulphate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
Unwanted effects:
Eurax Itch Relief Cream may occasionally cause skin irritation or allergy. If this occurs or if you experience other symptoms, stop using the product and consult your doctor. If Eurax Itch Relief Cream is accidentally swallowed, contact your nearest hospital casualty department or tell your doctor immediately. Use this medicine only on your skin.
8. EXPIRY DATE
EXP:
Do not use after the expiry date given.
9. SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
-
< not applicable >
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Thornton&Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK
<Company logo>
12. MARKETING AUTHORISATION NUMBER(S)
PL 00240/0461
13. BATCH NUMBER
BN:
14. GENERAL CLASSIFICATION FOR SUPPLY
-
< not applicable – GSL >
15. INSTRUCTIONS ON USE
Effective Relief of itching Works for up to 10 hours
For relief of itching and skin irritation caused by:
Itchy dermatitis
Dry eczema
Allergic rashes
A cream for the relief of itching and skin irritation caused by:
Itchy dermatitis
Dry eczema
Allergic rashes
Chickenpox
Insect bites & stings
Hives, nettle rash
Sunburn
Heat rashes
Personal itching
Suitable for adults and children; consult your doctor before use on children under 3 years of age.
Text prepared: March 2021
16. INFORMATION IN BRAILLE
Eurax Itch Relief Cream
PARTICULARS TO APPEAR ON THE INNER PACKAGING
LABEL
1. NAME OF THE MEDICINAL PRODUCT
Eurax Itch Relief Cream
-
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Active ingredient : Crotamiton
3. LIST OF EXCIPIENTS
Also contains Methyl hydroxybenzoate E218, phenylethyl alcohol, glycerol, triethanolamine, sodium lauryl sulphate, ethylene glycol monostearate, stearyl alcohol, strong ammonia solution, stearic acid, hard paraffin, white beeswax, purified water and Perfume (Contains: geraniol, citronellol, coumarin, benzyl alcohol (0.0187%), benzyl benzoate (0.0047%), citral, d-limonene, eugenol, linalool).
4. PHARMACEUTICAL FORM AND CONTENTS
Cream
30g , 100g
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Directions : Apply to the affected area 2–3 times daily. Irritation will be relieved for 6 to 10 hours. If symptoms persist consult your doctor. Eurax Itch Relief Cream can be used for children. For children under 3 years of age consult your doctor before use and do not apply more than once a day.
-
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Keep all medicines out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Cautions: Do not use i n or around the eyes, on broken skin, for weeping skin conditions or if you are sensitive to any of the ingredients. Eurax Itch Relief Cream is not recommended in pregnancy. Consult your doctor or pharmacist before using Eurax Itch Relief Cream if you are breast feeding or suffering from genital itching. May occasionally cause skin irritation or allergy. If this occurs or if you experience other symptoms, stop using the product and consult your doctor. If Eurax Itch Relief Cream is accidentally swallowed, contact your nearest hospital casualty department or tell your doctor immediately.
This medicine contains stearyl alcohol, methyl hydroxybenzoate which may cause allergic reactions /skin reactions e.g. contact dermatitis (possibly delayed) and perfume (including potential allergens benzyl alcohol(0.0187%), benzyl benzoate (0.0047%), citral, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool) which may cause allergic reactions. This medicine also contains 0.45% w/w sodium lauryl sulphate in each application. Sodium lauryl sulphate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
Use this medicine only on your skin.
8. EXPIRY DATE
Do not use after the expiry date given.
9. SPECIAL STORAGE CONDITIONS
Store below 25°C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
< not applicable >
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
12. MARKETING AUTHORISATION NUMBER(S)
PL 00240/0461
13. BATCH NUMBER
Batch number/EXP date: see end of tube.
14. GENERAL CLASSIFICATION FOR SUPPLY
-
< not applicable – GSL>
15. INSTRUCTIONS ON USE
Effective relief of itching
Works for up to 10 hours
For the relief of itching and skin irritation
16. INFORMATION IN BRAILLE
Eurax Itch Relief Cream
PARTICULARS TO APPEAR ON THE INNER PACKAGING
LABEL
-
1. NAME OF THE MEDICINAL PRODUCT
Eurax Itch Relief Cream
-
2. STATEMENT OF ACTIVE SUBSTANCE(S)
Active ingredient : Crotamiton
-
3. LIST OF EXCIPIENTS
Also contains Methyl hydroxybenzoate E218, phenylethyl alcohol, glycerol, triethanolamine, sodium lauryl sulphate, ethylene glycol monostearate, stearyl alcohol, strong ammonia solution, stearic acid, hard paraffin, white beeswax, purified water and Perfume (Contains: geraniol, citronellol, coumarin, benzyl alcohol (0.0187%), benzyl benzoate (0.0047%), citral, d-limonene, eugenol, linalool).
-
4. PHARMACEUTICAL FORM AND CONTENTS
Cream
30g , 100g
-
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Directions : Apply to the affected area 2–3 times daily. Irritation will be relieved for 6 to 10 hours. If symptoms persist consult your doctor. Eurax Itch Relief Cream can be used for children. For children under 3 years of age consult your doctor before use and do not apply more than once a day.
-
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Keep all medicines out of the sight and reach of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
Cautions: Do not use i n or around the eyes, on broken skin, for weeping skin conditions or if you are sensitive to any of the ingredients. Eurax Itch Relief Cream is not recommended in pregnancy. Consult your doctor or pharmacist before using Eurax Itch Relief Cream if you are breast feeding or suffering from genital itching. May occasionally cause skin irritation or allergy. If this occurs or if you experience other symptoms, stop using the product and consult your doctor. If Eurax Itch Relief Cream is accidentally swallowed, contact your nearest hospital casualty department or tell your doctor immediately.
This medicine contains stearyl alcohol, methyl hydroxybenzoate which may cause allergic reactions /skin reactions e.g. contact dermatitis (possibly delayed) and perfume (including potential allergens benzyl alcohol(0.0187%), benzyl benzoate (0.0047%), citral, citronellol, coumarin, d-limonene, eugenol, geraniol, linalool) which may cause allergic reactions. This medicine also contains 0.45% w/w sodium lauryl sulphate in each application. Sodium lauryl sulphate may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.
Use this medicine only on your skin.
-
8. EXPIRY DATE
Do not use after the expiry date given.
-
9. SPECIAL STORAGE CONDITIONS
Store below 25°C.
-
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL
< not applicable >
-
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
-
12. MARKETING AUTHORISATION NUMBER(S)
PL 00240/0461
-
13. BATCH NUMBER
Batch number/EXP date: see end of tube.
-
14. GENERAL CLASSIFICATION FOR SUPPLY
-
< not applicable – GSL>
-
15. INSTRUCTIONS ON USE
Effective relief of itching
Works for up to 10 hours
For the relief of itching and skin irritation
-
16. INFORMATION IN BRAILLE