Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Liquid paraffin light
Genus Pharmaceuticals Ltd
Liquid paraffin light
828mg/1gram
Bath additive
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020101; GTIN: 5030451003416
25188502 PA1D8221D Back label PRINTED ON WHITE Reverse of back label PRINTED ON WHITE ACTIVE INGREDIENTS: Light Liquid Paraffin Ph Eur 82.8% w/w. ALSO CONTAINS: C-12-13-Pareth-3 and medium chain triglycerides. PRECAUTIONS: Do not use if you are allergic to any of the ingredients. Mild skin reactions have been seen very rarely. This product makes skin and surfaces slippery. Take care not to slip when entering or leaving the bath. Avoid contact with the eyes. If product comes into contact with eyes, wash out with water. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. Do not store above 25°C. Do not use after expiry date. FURTHER INFORMATION: Cetraben Emollient Bath Additive is a fragrance free clear liquid. PRODUCT LICENCE HOLDER: Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK. PL 06831/0260 MANUFACTURED BY: Laleham Health & Beauty Ltd., Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Lancs. PR4 3JA, UK. ® Cetraben is a registered trademark. *Trademark Revised: March 2015 CETRABEN EMOLLIENT BATH ADDITIVE is an effective, moisturising and protective oil for the symptomatic relief of symptoms such as red, inflamed, damaged, dry or chapped skin especially when associated with eczema. MHRA HEADER BOX Product Title: Component: Pack size: IG Code: Dimensions: Proof No.: COLOURS USED FONTS USED Date: PCP HEADER BOX Operator: Artwork No: CRN: Reason for change: MHRA/IMB submission required: APPROVED BY DATE ISSUED BY DATE Suffix: A 9 Blackthorn Road. Reigate. RH2 7ND. Tel: 01737 240944 info@visivodesign.co.uk Cetraben Emollient Bath Additive Portrait single ply back and back reverse label 500ml 25188502 110 x 50mm 2955C 326C Tondo Tondo Bold Brail Lire le document complet
OBJECT 1 CETRABEN EMOLLIENT BATH ADDITIVE / CETRABEN BATH ADDITIVE Summary of Product Characteristics Updated 13-Feb-2018 | Genus Pharmaceuticals 1. Name of the medicinal product Cetraben Emollient Bath Additive Cetraben Bath Additive 2. Qualitative and quantitative composition Light Liquid Paraffin 82.8% w/w For excipients see section 6.1 3. Pharmaceutical form Bath additive Cetraben Emollient Bath Additive is a clear liquid with a faint odour. 4. Clinical particulars 4.1 Therapeutic indications Cetraben Emollient Bath Additive is an emollient, moisturising and protective oil for the symptomatic relief of red, inflamed, damaged, dry or chapped skin, especially when associated with endogenous or exogenous eczema. 4.2 Posology and method of administration Cetraben Emollient Bath Additive should be added to a warm water bath or applied to wet skin before showering. Bath: Adults: Add one/two capfuls to a warm water bath Children: Add half/one capfuls to a warm water bath Shower:. Apply lightly using a wet sponge 4.3 Contraindications Hypersensitivity to any of the ingredients 4.4 Special warnings and precautions for use Allergy to any of the ingredients. Care when entering or leaving the bath Avoid contact with eyes. 4.5 Interaction with other medicinal products and other forms of interaction None known 4.6 Fertility, pregnancy and lactation No special precautions required 4.7 Effects on ability to drive and use machines None 4.8 Undesirable effects Very rarely, mild skin reactions have been seen REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for 'MHRA Yellow Card' in the Google Play or Apple App Store. 4.9 Overdose No cases of overdose have been reported. Patients should be advised that if they accide Lire le document complet