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Eurax Lotion

Document: label-leaflet MAH BRAND_PL 44673-0114 change

Eurax lotion - PL 44673/0114 - Label

PARTICULARS TO APPEAR ON THE INNER PACKAGING


TEXT ON LABEL


1. NAME OF THE MEDICINAL PRODUCT


Eurax Lotion Crotamiton


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Crotamiton 10% w/w


3. LIST OF EXCIPIENTS


glycerol monostearate, sorbic acid, citric acid monohydrate, phenylethyl alcohol, propylene glycol, perfume, cetomacrogol, stearyl alcohol, sodium cetylstearyl sulphate and 2-octyl dodecanol.


4. PHARMACEUTICAL FORM AND CONTENTS


100ml


5.    METHOD AND ROUTE(S) OF ADMINISTRATION


Keep out of the reach and sight of children. Do not use after the expiry date given.


7.    OTHER SPECIAL WARNING(S), IF NECESSARY


Cautions: 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. Eurax Lotion is not recommended in pregnancy. Consult your doctor or pharmacist before using Eurax Lotion if you are breast feeding, or suffering from genital itching. May occasionally cause skin irritation or allergy. If this occurs or you experience other symptoms stop using the product and consult your doctor. If Eurax is accidentally swallowed, contact your nearest hospital casualty department or tell your doctor immediately


8. EXPIRY DATE


EXP


9. SPECIAL STORAGE CONDITIONS


Do not store above 25 °C


10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


N/A


11.    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER


GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford,

TW8 9GS,


UK.


PL 44673/0114

13. BATCH NUMBER<, DONATION AND PRODUCT CODES> LOT

14. GENERAL CLASSIFICATION FOR SUPPLY


15. INSTRUCTIONS ON USE


Stops itching fast Works for up to 10 hours

For relief of itching and skin irritation caused by

•    Itchy dermatitis

•    Dry eczema

•    Allergic rashes

•    Hives, nettle rash

•    Chickenpox

•    Insect bites & stings

•    Heat rashes

•    Sunburn

•    Personal itching

Shake before use. 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 can be used for children. Children under 3 years: consult your doctor before use. Eurax is also available as a non-greasy cream in 30 g and 100 g tubes.

Braill included on the outer carton.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING


TEXT ON CARTON


1. NAME OF THE MEDICINAL PRODUCT


Eurax Lotion Crotamiton


2. STATEMENT OF ACTIVE SUBSTANCE(S)


Crotamiton 10% w/w


3. LIST OF EXCIPIENTS


glycerol monostearate, sorbic acid, citric acid monohydrate, phenylethyl alcohol, propylene glycol, perfume, cetomacrogol, stearyl alcohol, sodium cetylstearyl sulphate and 2-octyl dodecanol.


4. PHARMACEUTICAL FORM AND CONTENTS


100ml


5. METHOD AND ROUTE(S) OF ADMINISTRATION


Keep out of the reach and sight of children. Do not use after the expiry date given.


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.

Cautions: Eurax Lotion is not recommended in pregnancy. Consult your doctor or pharmacist before using Eurax Lotion if you are breast feeding, or suffering from genital itching.

This product contains propylene glycol which may cause skin irritation, sorbic acid and stearyl

alcohol which may cause local skin reactions (e.g. contact dermatitis).

If this occurs or if you experience other symptoms stop using the product and consult your doctor.

If Eurax is accidentally swallowed, contact your nearest hospital casualty department or tell your doctor immediately.


8. EXPIRY DATE


EXP


9. SPECIAL STORAGE CONDITIONS


Do not store above 25 °C


10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE


N/A


11.    NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER


GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford,

TW8 9GS,

UK.


12. MARKETING AUTHORISATION NUMBER(S)


PL 44673/0114


13. BATCH NUMBER<, DONATION AND PRODUCT CODES> LOT


14. GENERAL CLASSIFICATION FOR SUPPLY


15. INSTRUCTIONS ON USE


Stops itching fast Works for up to 10 hours

For relief of itching and skin irritation caused by

•    Itchy dermatitis

•    Dry eczema

•    Allergic rashes

•    Hives, nettle rash

•    Chickenpox

•    Insect bites & stings

•    Heat rashes

•    Sunburn

•    Personal itching

A non-staining lotion for the relief of itching and skin irritation.


Shake before use. 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 can be used for children. Children under 3 years: consult your doctor before use. Eurax is also available as a non-greasy cream in 30 g and 100 g tubes.

16. INFORMATION IN BRAILLE


Eurax Lotion