Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Urea; Lauromacrogols
DE Pharmaceuticals
D02AE51
Urea; Lauromacrogols
50mg/1gram ; 30mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13020100
ARTWORK INFORMATION PANEL DESCRIPTION: PRINTING COLOURS NON PRINTING COLOURS COLOUR REFERENCE IN PMS BRIDGE EQUATE WITH CMYK PROOF: REGULATORY TEXT: ITEM NUMBER: MATERIAL SIZE: DESIGNER: FONTS: FONT SIZE: DATE: MANUFACTURER’S TECHNICAL CHECK: Manufacturer confirms the printability and technical compliance of this packaging material for correct use during packaging process. Date and Signature INLINE CONTROL CODE P Process Yellow CP LBL Balneum Plus Cream 500 g GB Mock up uk-labelling OCEAN SANS MT SEMIBOLD / BOLD / Book, Franklin Gothic Medium, Helvetica Neue LT Pro Roman 00000000 230 x 130 mm 03.09.2019 7pt 1 Die cut Braille P293 Yellow P Bright orange P311 P Black Balneum Plus Cream is an easily absorbed cream containing an ingredient called lauromacrogols which relieves itching. It has a soothing and softening effect on your skin and also works by replacing the much needed oils in your dry skin. This helps to prevent loss of skin moisture. The cream also contains urea. This substance is found naturally in the skin and helps the skin to retain water. Many people with eczema and psoriasis have reduced amounts of urea in their skin and Balneum Plus Cream can help by replacing it. This cream has been shown to increase skin moisture for up to 24 hours. The indicated skin conditions worsen when the skin is allowed to become dry. DO NOT USE: • If you are allergic (hypersensitive) to urea, lauromacrogols or to any of the other ingredients. • If you are suffering from severe and widespread reddening of the skin. • If the affected area has suddenly become inflamed or is oozing and/or infected. • On the breasts immediately prior to breast feeding. • Talk to your doctor before using Balneum Plus Cream in children. WARNINGS AND PRECAUTIONS: Your medicine may cause irritation if applied to broken or inflamed skin. Avoid contact to mucous membranes and eyes. DIRECTIONS: For external use by adults, the elderly and children. Using clean hands, apply the cream to the affected areas twice a day until the symptoms have Lees het volledige document
1. NAME OF THE MEDICINAL PRODUCT Balneum Plus Cream Lauromacrogols 3.0% w/w and Urea 5.0% w/w, Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Percentage (w/w) Lauromacrogols 3.0% Urea 5.0% 3 PHARMACEUTICAL FORM Cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/ or hydrating effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, the Elderly and Children: Balneum Plus Cream should be applied to each affected area twice a day. The duration of treatment depends on the clinical response. 4.3 CONTRAINDICATIONS Patients with known hypersensitivity to any of the ingredients. It should not be used to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact to mucous membranes and eyes. Irritation (e.g. erythema, burning) may occur if applied to broken or inflamed skin. Benzyl alcohol may cause allergic reactions and mild local irritation. Children/Pediatric population: Reports from the literature suggest that the use of urea-containing products in children may lead to a usually brief burning sensation on the skin. 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 Urea may increase the penetration through the skin barrier of other topically applied medicines (e.g. corticosteroids, dithranol and fluorouracil) when used at the same time 4.6 FERTILITY, PREGNANCY AND LACTATION For Balneum Plus Cream no clinical data on exposed pregnancies are available. Animal studies do not indicate direct o Lees het volledige document