Emoderm Cream 5p3o

For the use only of ed Medical Practitioners or a Hospital or a Laboratory EMODERM CREAM White Soft Paraffin Cream QUALITATIVE AND QUANTITATIVE COMPOSITION Emollient Cream base containing Benzoic Acid I.P. 0.2% w/w (as preservative) PHARMACEUTICAL FORM Cream. CLINICAL PARTICULARS Therapeutic Indications Treatment of dry skin conditions including eczema, ichthyosis and pruritus of the elderly. Posology and Method of istration For topical use only. May be used as frequently as necessary. Adults, adolescents and children Apply to the skin as required and smooth into the skin in the direction of hair growth. Elderly No dosage adjustment is necessary. Renal impairment No dosage adjustment is necessary. Hepatic impairment No dosage adjustment is necessary. Contraindications Hypersensitivity to any of the ingredients. Special Warnings and Special Precautions for Use For external use only. Keep out of reach of children. Guard against slipping. Discontinue use if the condition is made worse. Do not apply to broken skin.

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Patients being dispensed or treated with large quantities (> 100g) of any paraffin based product should be advised to regularly change clothing or bedding impregnated with the product and keep away from naked flames as there is a fire hazard. Interaction with Other Medicaments and Other Forms of Interaction None identified. Pregnancy and Lactation Fertility No data available on the use of EMODERM Cream on human fertility. Pregnancy Can be used. Lactation Can be used. Effects on Ability to Drive and Use Machines Not relevant. Undesirable Effects May cause dermatitis. Overdose Symptoms and signs The product is intended for topical use only. Accidental ingestion may cause gastrointestinal irritation with nausea, vomiting and diarrhoea. Treatment In case of ingestion, management should be as clinically indicated or as recommended by the national poisons centre, where available. PHARMACOLOGICAL PROPERTIES Pharmacodynamic Properties Pharmacotherapeutic Group: Dermatologicals, other emollients and protectives; ATC code : D02AX Pharmacodynamic Effects 2

Emollients are fats or oils used for their local action on the skin and, occasionally, the mucous membranes. These oleaginous substances, also known as occlusive agents and humectants, are employed as protectives and as agents for softening the skin and rendering it more pliable. White soft paraffin forms an effective occlusive lipid film. The mechanism of action is by occluding water loss from the outer layer of skin. Pharmacokinetic Properties White soft paraffin exerts its physiological effects by forming an occlusive layer on the surface of the skin. It is effective because it is not subject to absorption or subsequent distribution in the body, excretion or metabolism. Pharmacokinetic particulars are not appropriate in these circumstances. Preclinical Safety Data No relevant pre-clinical data has been generated. PHARMACEUTICAL PARTICULARS List of Excipients White Soft Paraffin, Stearyl Alcohol, Cetyl Alcohol, Polysorbate 60, Isopropyl Myristate, Propylene Glycol, Benzoic Acid, Glycerin, Perfume Compound FL, Purified water. Incompatibilities No incompatibilities have been identified. Shelf Life The expiry date is indicated on the label and packaging. Special Precautions for Storage Store in a cool place, at a temperature not exceeding 25oC. Do not freeze. Keep out of reach of children. Nature and Specification of Container Tube in a carton Instructions for Use / Handling For external use only. There are no other special requirements for use or handling of this product. For further information please : 3

GlaxoSmithKline Pharmaceuticals Limited. ed Office Dr. Annie Besant Road, Worli Mumbai 400 030, India. Trade marks are owned by or licensed to the GSK group of companies Version EMO/PI/IN/2018/01 dated 01 March 2018 Adapted from : • Dermamist SPC (updated on eMC 27-Mar-2015, date of revision of the text 3rd February 2015). • White soft paraffin-light liquid paraffin GDS Version 01 dated 24 September 2012.

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