Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Liquid paraffin light; White soft paraffin
Thornton & Ross Ltd
Liquid paraffin light; White soft paraffin
60mg/1gram ; 150mg/1gram
Cutaneous cream
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020100; GTIN: 5011091102844 5011091103339 5011091105678 5011091105753
DIRECTIONS Apply to the affected area. Use as often as required or as directed by your pharmacist or doctor. OILATUM ® JUNIOR CREAM is especially effective if applied immediately after washing, to counteract the loss of essential oils from the skin. OILATUM ® JUNIOR CREAM is suitable for children and babies. MARKETING AUTHORISATION HOLDER AND MANUFACTURER: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK. PL 00240/0467 Date of information: September 2020 ACTIVE INGREDIENTS light liquid paraffin 6.0% w/w, white soft paraffin 15.0% w/w. OTHER INGREDIENTS: Macrogol 1000 Monostearate, Cetostearyl Alcohol*, Glycerol, Potassium Sorbate*, Benzyl Alcohol (0.5%w/w)*, Citric Acid Monohydrate, Povidone, Purified Water. *May cause allergic/local skin reactions or irritation (e.g. contact dermatitis). Do not use the product after the expiry date. Store below 25ºC. 150 G OILATUM ® JUNIOR CREAM is an emollient (softening, soothing agent) and has been specially developed for children and babies. It is used in the treatment of eczema and related dry skin conditions. OILATUM ® JUNIOR CREAM forms a protective film which moisturises, soothes, softens and rehydrates the skin. It is especially effective after washing. It is suitable for people allergic to lanolin. Fragrance free SOOTHES, SOFTENS AND REHYDRATES RELIEVES ITCHING SUITABLE FOR BABIES AND CHILDREN JUNIOR CREAM NEW SAFETY INFORMATION – SEE LABEL 92961212009 FOR ECZEMA AND RELATED DRY SKIN CONDITIONS JUNIOR CREAM Cream light liquid paraffin white soft paraffin FIRE HAZARD. DO NOT SMOKE OR GO NEAR NAKED FLAMES; CLOTHING & BEDDING WITH THIS PRODUCT DRIED ON THEM CAN CATCH FIRE EASILY. WARNINGS Avoid using the product if you are sensitive to any of the ingredients. If an adult uses this product whilst breast-feeding, wash all traces prior to feeding. 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 ma Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oilatum Cream Oilatum Junior Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base. Also contains cetostearyl alcohol and potassium sorbate. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Cream. A white to off-white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oilatum Cream is indicated in the treatment of contact dermatitis, atopic eczema, senile pruritus, ichthyosis and related dry skin conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oilatum Cream may be used as often as required. Apply to the affected area and rub in well. It is especially effective after washing when the sebum content of the stratum corneum may be depleted resulting in excessive moisture loss. Oilatum Cream is suitable for adults, children and the elderly. 4.3 CONTRAINDICATIONS Should not be used in patients with known hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Oilatum Cream should be used with caution in patients with a known sensitivity or allergy to white soft paraffin or light liquid paraffin (WSP-LLP) or to any of the excipients in the preparation. Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis). Instruct patients not to 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. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 FERTILITY, PREGNANCY AND LACTATION FERTILITY There are no data on the use of topical Oilatum Cream on human fertility PREGNANCY There are no data on the use of topical Oilatum Cream in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to WSP- LLP i Read the complete document