Cetraben Prescribing Information

Please refer to the Medical Device Core Data sheet before prescribing

Cetraben Cream:

Manufacturer: Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK

Code # of Notified Body: N/A

Legal classification: Class I

Product name: Cetraben Cream

Ingredients: Purified Water, White Soft Paraffin 13.2% w/w, Light Liquid Paraffin 10.5% w/w, Emulsifying Wax (SLS free), Polysorbate 60, Glycerol, Cetostearyl Alcohol, Phenoxyethanol, Sodium Citrate, Citric Acid Monohydrate.

Indications: Cetraben Cream is an emollient, moisturising and protective cream for the symptomatic relief of red, inflamed, dry skin, especially when associated with eczema.

Adverse reactions: 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. This product contains cetostearyl alcohol which may cause local skin reactions.

Precautions: Do not use if you are allergic to any of the ingredients listed. If the skin is badly cracked, infected or bleeding do not apply; seek medical advice before use. Avoid contact with the eyes. If you accidentally swallow this product, seek medical advice and take the pack with you to show which product has been swallowed. For external use only. Do not use if tamper evident collar is broken or missing at first use (500g packs). Using Cetraben Cream during pregnancy and breastfeeding is unlikely to have any ill effects. If unsure, talk to your doctor or pharmacist. Keep out of the sight and reach of children. Do not use after expiry date. Fire hazard. Do not smoke or go near naked flamed; clothing or bedding with this product dried on them can catch fire easily. Washing clothing and bedding may reduce product build-up but not totally remove it. Use within 3 months of opening.

Contra-indications: Hypersensitivity to any of the ingredients.

Method of administration: Prime the pump before first use by depressing fully until cream appears. If the pump stops working do not dismantle the pack. Re-start by covering the nozzle, then fully depress the pump several times to expel air. Adults, the elderly and children over 1 year: Wash and dry hands before use. Apply to dry skin areas as often as required and smooth gently into the skin following the direction of hair growth. Children under 1: Seek HCP advice before use.

Date of preparation: 22/03/2021

Adverse incidents should be reported on 01484 848164, at thorntonross@medinformation.co.uk or alternatively at www.mhra.gov.uk/yellowcard.

Please refer to the Medical Device Core Data sheet before prescribing

Cetraben Ointment:

Manufacturer: Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK

Code # of Notified Body: N/A

Legal classification: Class I

Product name: Cetraben Ointment

Ingredients: Light Liquid Paraffin 45% w/w, White Soft Paraffin 35% w/w, Cetostearyl Alcohol, Polysorbate 60

Indications: An emollient used to moisturise and soften dry skin in eczema, dry cases of psoriasis and other dry skin conditions. Also used as a skin cleanser or bath additive.

Adverse reactions: There are no known side effects. In the unlikely event of a side effect you should stop use and talk to your doctor or pharmacist. This product contains cetostearyl alcohol which may cause local skin reactions.

Precautions: Do not use if you are allergic to any of the ingredients listed. If the skin is badly cracked, infected or bleeding do not apply; seek medical advice before use. Avoid contact with eyes. Bath and showers may become slippery. Take care not to slip. Clean away any residues with household cleaner using warm water. For external use only. If you accidentally swallow some see a doctor straight away. Show this label or pack. Using Cetraben Ointment during pregnancy and breastfeeding is unlikely to have any ill effects. If unsure, talk to your doctor or pharmacist. Do not refrigerate or freeze. Do not use after expiry date. Fire hazard. Do not smoke or go near naked flames; clothing or bedding with this product dried on them can catch fire easily. Washing clothing and bedding may reduce product build-up but not totally remove it. Use within 3 months of opening.

Contra-indications: Hypersensitivity to any of the ingredients.

Method of administration: Adults, the elderly and children over 1 year: Wash hands before and after use. Apply to dry skin areas as often as required. Smooth gently into the skin following direction of hair growth. Children under 1: Seek HCP advice before use. As a bath additive: Melt about 4g (roughly a teaspoonful) of Cetraben Ointment in hot water in a suitable container. Then add to the bath ensuring that the water has sufficiently cooled before getting in. As a soap substitute: Take a small amount of Cetraben Ointment from the tub, lather it under warm water and use as required when washing or in the shower. Pat skin dry.

Date of preparation: 22/03/2021

Adverse incidents should be reported on 01484 848164, at thorntonross@medinformation.co.uk or alternatively at www.mhra.gov.uk/yellowcard.

Please refer to the Medical Device Core Data sheet before prescribing

Cetraben Lotion:

Manufacturer: Thornton & Ross Ltd, Linthwaite, Huddersfield, HD7 5QH, UK

Code # of Notified Body: N/A

Legal classification: Class I

Product name: Cetraben Lotion

Ingredients: Purified Water, Emulsifying Wax (SLS free), White Soft Paraffin 5% w/w, Light Liquid Paraffin 4% w/w, Glycerol, Phenoxyethanol, Cetostearyl Alcohol.

Indications: A lotion used for the relief of the symptoms of eczema, dermatitis and other dry skin conditions.

Adverse reactions: Mild skin reactions, such as redness and rash, have been seen very rarely. In the unlikely event of side effects, you should talk to your doctor or pharmacist. This product contains cetostearyl alcohol which may cause local skin reactions.

Precautions: Do not use if you are allergic to any of the ingredients listed. If the skin is badly cracked, infected or bleeding do not apply; seek medical advice before use. Avoid contact with the eyes. If you accidentally swallow this product see a doctor straight away. Show this label or pack. For external use only. Do not use if tamper evident collar is broken or missing at first use (500ml). Using Cetraben Lotion during pregnancy and breastfeeding is unlikely to have any ill effects. If unsure, talk to your doctor or pharmacist. Keep out of the sight and reach of children. Do not refrigerate or freeze. Do not use after expiry date. Fire hazard. Do not smoke or go near naked flames; clothing or bedding with this product dried on them can catch fire easily. Washing clothing and bedding may reduce product build-up but not totally remove it. Use within 3 months of opening.

Contra-indications: Hypersensitivity to any of the ingredients.

Method of administration: Prime the pump before first use by depressing fully until cream appears. If the pump stops working do not dismantle the pack. Re-start by covering the nozzle, then fully depress the pump several times to expel air. Adults, the elderly and children over 1 year: Wash and dry hands before use. Apply to dry skin areas as often as required, or as directed by your doctor or pharmacist. Smooth gently into the skin, following the direction of hair growth. Children under 1: Seek HCP advice before use.

Date of preparation: 22/03/2021

Adverse incidents should be reported on 01484 848164, at thorntonross@medinformation.co.uk or alternatively at www.mhra.gov.uk/yellowcard.

Please refer to the Summary of Product Characteristics or Core Data sheet before prescribing

Cetraben Emollient Bath Additive:

Product Authorisation Holder: Genus Pharmaceuticals Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.

Marketing Authorisation number: PL 06831/0260.

Legal classification: GSL.

Product name: Cetraben Emollient Bath Additive.

Ingredients: Light Liquid Paraffin.

Indications: Symptomatic relief of red, inflamed, damaged, dry or chapped skin, especially when associated with endogenous or exogenous eczema.

Adverse reactions: Very rarely, mild skin reactions have been seen.

Precautions: Allergy to any of the ingredients. Care should be taken when entering or leaving the bath. Avoid contact with eyes. 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.

Contra-indications: Hypersensitivity to any of the ingredients.

Dosage, method of use and method of administration: As a bath additive: Add to a warm water bath (1-2 capfuls for adults, ½-1 capfuls for children). Alternatively, apply lightly to wet skin with a sponge before showering.

The cost (ex VAT) of the advertised pack sizes: 500ml = £5.75.

Date of preparation: 13/09/2019.

Adverse incidents should be reported on 01484 848164, at thorntonross@medinformation.co.uk or alternatively at www.mhra.gov.uk/yellowcard.