Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Liquid paraffin; White soft paraffin; Emulsifying wax
Ovelle Limited
D02AX
Liquid paraffin; White soft paraffin; Emulsifying wax
30%w/w + 50%w/w + 20 percent weight/weight
Ointment
Product not subject to medical prescription
Other emollients and protectives
Marketed
1988-11-18
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Emulsifying Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Emulsifying wax 30% w/w [Cetostearyl Alcohol Sodium Lauryl Sulphate Purified Water] White soft paraffin 50% w/w Liquid paraffin 20% w/w 3 PHARMACEUTICAL FORM Ointment. White semi-opaque ointment with characteristic odour and smooth texture. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS a) Moisturiser and emollient that soothes and helps to hydrate dry skin. b) Soap substitute. Eczema and other dry skin conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply as often as required to prevent itching and flaking dry skin. Soap substitute. See patients information sheet. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Sodium laurilsulfate (E 487) may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area.Sensitivity to SLS can vary according to body site, age and patient population (children, hydration level, skin color and disease). Patient populations with decreased skin barrier functions such as in atopic dermatitis are more sensitive to the irritant properties of SLS. Adults: as above Babies: as above Elderly: as above H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _7_ _/_ _1_ _1_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ Прочетете целия документ