Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Liquid paraffin light
Thornton & Ross Ltd
Liquid paraffin light
634mg/1ml
Bath additive
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020101; GTIN: 5011091102028 5011091102080
62000000041848 BATH EMOLLIENT FOR THE TREATMENT OF DRY AND ITCHY SKIN CONDITIONS INCLUDING ECZEMA AND DERMATITIS light liquid paraffin Emollient NEW SAFETY INFORMATION – SEE LABEL 500 ML MARKETING AUTHORISATION HOLDER: Thornton & Ross Ltd., Huddersfield, HD7 5QH, UK. MANUFACTURER: Stiefel Laboratories (Ireland) Ltd. Finisklin Business Park, Sligo, Ireland. Braille reads: oilatum emollient O I L A T U M E M O L L I E N T Product Title: Pack Size: Mat.No: Dimensions: Keyline Reference: Barcode: Pharmacode: Datamatrix: Reason for Change: 1. Fonts Used: Point Size Used: 2. Fonts Used: Min: Max: Proof Number: Date: Operator: Artwork Number: CRN: Suffix: Local Authority submission required: Approved by: Date: Issued by: Date: Point Size Used: Min: Max: 1. Colour: 2. Colour: 3. Colour: 4. Colour: 5. Colour: 6. Colour: 7. Colour: 8. Colour: 9. Colour: 10.Colour: 500ML 92901391908_LFR 65 X 140MM CYAN BRAILLE (NON-PRINTING) CIRRUS_INFO_BOX INDICATION OF BOTTLE COLOR KEYLINE (NON-PRINTING) PANTONE 2747 C UNIVERSAL VARNISH - GLOSS VARNISH - MATT WHITE 1 ITC AVANT GARDE GOTHIC PRO 6PT 8PT 1 29.08.2019 1067982 16207 A YES CHANGE MAH FROM GSK TO T&R OILATUM EMOLLIENT UK Lot: Exp: DIRECTIONS ACTIVE INGREDIENTS WARNINGS 62000000041849 light liquid paraffin BP 63.4% w/w OTHER INGREDIENTS: Acetylated Lanolin Alcohols, Isopropyl Palmitate, Macrogol 400 Dilaurate, Macrogol Ester, Fragrance. PL 00240/0463. Date of information: August 2019 OILATUM EMOLLIENT should always be used with water. ADULTS, INCLUDING THE ELDERLY: Add 1-3 capfuls to an 8 inch bath of water. Bathe for 10-20 minutes. Pat dry with a towel. Alternatively, rub a small amount onto wet skin, rinse off and pat dry. INFANTS AND CHILDREN: As above, or add ½ to 2 capfuls to a small bath of water. Apply gently over the entire body with a sponge. Pat dry with a towel. SKIN CLEANSING: Rub a small amount into wet skin, rinse off and pat dry. Take care against slipping in the bath. Avoid contact with eyes. Do not smoke or go near naked flames - risk of severe burns. Fabric Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oilatum Bath Formula Oilatum Emollient 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Light Liquid Paraffin 63.4% w/w 3 PHARMACEUTICAL FORM Liquid Bath Additive 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oilatum Emollient is indicated in the treatment of contact dermatitis, atopic dermatitis, senile pruritus, ichthyosis and related dry skin conditions. Oilatum Emollient replaces oil and water and hydrates the keratin. Oilatum Emollient is particularly suitable for infant bathing. The preparation also overcomes the problem of cleansing the skin in conditions where the use of soaps, soap substitutes and colloid or oatmeal baths proves irritating. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oilatum Emollient should always be used with water, either added to the water or applied to wet skin. Adult bath: Add 1-3 capfuls to an 8-inch bath of water, soak for 10-20 minutes. Pat dry. Infant bath: Add ½-2 capfuls to a basin of water, Apply gently over entire body with a sponge. Pat dry. Skin cleansing: Rub a small amount of oil into wet skin. Rinse and pat dry. Where conditions permit, and particularly in cases of extensive areas of dry skin, Oilatum Emollient should be used as a bath oil, ensuring complete coverage by immersion. In addition to the therapeutic benefits, this method of use provides a means of sedating tense patients, particularly relevant in cases of acute pruritic dermatoses where relaxation of tension appears to relieve symptoms. The product is suitable for use in adults, children and the elderly. 4.3 CONTRAINDICATIONS None 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The patient should be advised to use care to avoid slipping in the bath. If a rash or skin irritation occurs, stop using the product and consult your doctor. Oilatum Emollient should be used with caution in patients with a known sensitivity or allergy to light liquid paraffin (LLP) or to any of the excipients in the preparation. Instruct patients not to smoke or go near na Read the complete document