Cetraben Emollient cream – patient leaflet, side effects, dosage

1. NAME OF THE MEDICINAL PRODUCT

Cetraben Emollient 10.5, 13.2 % w/w Cream

Light Liquid Paraffin, White Soft Paraffin

2. STATEMENT OF ACTIVE SUBSTANCE(S)

This product contains 10.5% w/w Light Liquid Paraffin.

This product contains 13.2% w/w White Soft Paraffin.

3. LIST OF EXCIPIENTS

Emulsifying wax BP (Containing Cetostearyl alcohol and Sodium laurilsulfate), Cetostearyl Alcohol BP, Glycerin BP (E422), Butylparaben, Methylparaben (E218), Ethylparaben (E214), Propylparaben, Phenoxyethanol BP, Citric Acid, Purified Water.

4. PHARMACEUTICAL FORM AND CONTENTS

Cream

1050g

500g

150g

125g

50g

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Apply to dry skin areas as often as required and rub in.

Read the package leaflet before use.

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT

OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

1. 7. OTHER SPECIAL WARNING(S), IF NECESSARY

Do not use if you are allergic to any of the ingredients. Mild skin reactions, such as redness and rash, have been seen very rarely. Should this occur, use of the product should be stopped. In the unlikely event of side-effects, you should talk to your doctor or pharmacist. If you accidentally swallow this product, go to your nearest accident and emergency department. This product contains methylparaben, ethylparaben and propylparaben which may cause allergic reactions (possibly delayed).

This product contains Cetostearyl alcohol and 0.49% w/w Sodium laurilsulfate which may cause local skin reactions (such as stinging or burning sensations) or increased skin reactions caused by other products when applied on the same area.

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.

Flash warning: New safety information – see label

1. 8. EXPIRY DATE

EXP

1. 9. SPECIAL STORAGE CONDITIONS

Do not sore above 25

1. 10.

   SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS

   OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

2. 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Genus Pharmaceuticals,

Linthwaite,

Huddersfield,

HD7 5QH, UK.

1. 12. MARKETING AUTHORISATION NUMBER(S)

PL 06831/0259

1. 13. BATCH NUMBER<, DONATION AND PRODUCT CODES>
2. 14.

   GENERAL CLASSIFICATION FOR SUPPLY

   Fire hazard. Do not smoke or go near naked flames; clothing & bedding with this product dried on them can catch fire easily.

GSL

1. 15. INSTRUCTIONS ON USE
2. 16. INFORMATION IN BRAILLE
3. 17. UNIQUE IDENTIFIER – 2D BARCODE
4. 18. UNIQUE IDENTIFIER - HUMAN READABLE DATA