Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Light liquid paraffin; Lanolin anhydrous; White soft paraffin
Reckitt Benckiser Ireland Ltd
D02AX
Light liquid paraffin; Lanolin anhydrous; White soft paraffin
14.5%w/w +12.6%w/w+1.0 percent weight/weight
Cream
Product not subject to medical prescription
Other emollients and protectives
Marketed
1977-04-01
500G Pump Label DERMATLOGICAL E45 Cream White Soft Paraffin 14.5% w/w Light Liquid Paraffin 12.6% w/w Anhydrous Lanolin 1.0% w/w Treatment for DRY Skin Conditions This pump pack incorporates: Visibility strip to indicate how much cream is left Simple twist and lock pump Effective and pleasant to use, E45 CREAM has been clinically proven to treat and sooth dry, itching, flaking, chapped, rough and calloused skin, sunburn and detergent hands. It’s non-greasy emollient formulation is quickly absorbed by your skin, leaving it soft comfortable and relived. E45 CREAM is recommended for more serious dry skin conditions such as eczema, dermatitis and ichthyosis and as an adjunctive therapy in the treatment of psoriasis. E45 CREAM can be used every day by the whole family including babies. Also available in 15g, 50g, 125g and 350g* *Not all pack sizes are necessarily marketed. Clinically Proven – Perfume Free – Dermatologically Tested – Allergy Screened DIRECTIONS: Twist pump to OPEN position. Depress pump to dispense cream. Twist pump back to lock. Each actuation of the pump dispenses approx. 4g of cream. Apply liberally 2 or 3 times daily, or as required. For external use only. Do not use on mucous membranes or broken skin. Consult your doctor or pharmacists before use if breast feeding. Do not use if allergic to any of the active ingredients. Side effects may include acne, pneumonia lipoid symptoms including fatigue, fever, night sweats, dry cough and hypersensitivity possibly taking the form of an allergic rash. If you suspect an allergic reaction stop using the product. Patients being treated with large quantities (>100g) of any paraffin-based product are advised to 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. If symptoms persist or anything unusual happens, talk to your Прочитать полный документ
Health Products Regulatory Authority 13 December 2021 CRN00CGYV Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT E45 CreamWhite Soft Paraffin 14.5% w/wLight Liquid Paraffin 12.6% w/wAnhydrous Lanolin 1.0% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION White soft paraffin 14.5 % w/w Light liquid paraffin 12.6 % w/w Anhydrous lanolin 1.0 % w/w Also contains: Cetyl alcohol 0.5% w/w Methyl Hydroxybenzoate (E218) 0.15% w/w Proryl Hydroxybenzoate (E216) 0.04% w/w 3 PHARMACEUTICAL FORM Cream Smooth white or practically white cream with not more than a slight odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of dry skin conditions, where the use of an emollient is indicated, such as flaking, chapped skin, ichthyosis, dermatitis, sunburn, the dry stage of eczema and for the use as emollient adjunctive therapy in the treatment of dry cases of psoriasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Adults, Children, Babies and the Elderly - Apply to the affected part two or three times daily. METHOD OF ADMINISTRATION For topical application. 4.3 CONTRAINDICATIONS Hypersensitivity to white soft paraffin, light liquid paraffin and anhydrous lanolin or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. If hypersensitivity occurs, such as a rash, use of the product should be discontinued. May cause allergic reactions (possibly delayed), such as local skin reactions. If rash develops, use of the product should be discontinued. Patients being dispensed or treated with large quantities (>100g) of any paraffin-based product should be advised to regularly change clothing, bedding or dressings impregnated with the product and keep away from naked flames as there is a fire hazard, and as such should avoid smoking. The product should not be applied to the mucous membranes or to broken skin. Health Products Regulatory Authority 13 December 2021 CRN00CGYV Page 2 of 4 4.5 INTERACTION WITH OTHER MEDICINAL Прочитать полный документ