PRODUCT INFORMATION
Balneum Cream
Ingredients:
Urea 5 %, Ceramide NP, Aqua, Glycine Soya Oil, Propylene Glycol, Cetearyl Alcohol,
Liquid Paraffin, Isohexadecane, Sodium Lactate, Lactic Acid, PEG-20 Stearate, Polysorbate 60,
Squalane, Stearic Acid, Disodium EDTA, Lecithin, Tocopherol, Ascorbyl Palmitate, Hydrogenated
Palm Glycerides Citrate. Balneum Cream is free of fragrances, colourants and preservatives.
Pharmaceutical form:
White cream.
Indications:
Balneum Cream is formulated to protect the
skin, to maintain skin moisture and to restore the impaired skin barrier in conditions giving rise
to dry skin. It contains urea, ceramide NP and physiological lipids. Urea is known to increase
the skins ability to retain water and maintain skin hydration. Ceramide NP is known to help
restore the barrier function of skin. Balneum Cream is designed for daily use to relieve dry
and very dry skin conditions including eczema, psoriasis and other dermatological conditions.
Method of administration:
Using clean hands, apply the cream to the skin once or twice daily.
Contraindications:
Patients with known hypersensitivity to any of the ingredients, soya or
peanut.
Warnings and precautions:
For topical use only. Do not use on broken or inflamed skin.
Caution should be exercised with concomitant treatment with other medicated topical products.
If the condition becomes worse or if patients experience side effects/adverse incidents, discontinue
treatment with Balneum Cream and seek medical advice.
Adverse incidents:
Although very
few adverse incidents have been reported, the most frequent are local skin reactions.
Special
precautions for storage:
Do not store above 25°C. Use within 6 months of first opening
Pack
sizes:
Available in 50g (£2.85) and 500g (£9.97) pump dispensers.
CE marking held by:
Almirall
Hermal GmbH, Scholtzstraße 3, 21465 Reinbek, Germany
Distributed in the UK by:
Almirall Ltd,
1 The Square, Stockley Park, Uxbridge, UB11 1TD
Date of Revision:
02/2015.
Item code:
UKSOY3039.
Adverse incidents should be reported. Online reporting forms and information can be found
at
. Adverse incidents should also be reported to Almirall Ltd.
Adverse events should be reported. Reporting forms and information can be found at
. Adverse events should also be reported to Almirall Ltd.
Solutions with you in mind
PRESCRIBING INFORMATION
(Please consult the Summary of Product Characteristics (SmPC) before prescribing.)
Balneum Plus Cream
Lauromacrogols 3.0 % w/w and urea 5.0 % w/w.
Active Ingredient:
lauromacrogols 3.0 % w/w
and urea 5.0 % w/w.
Indication:
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.
Dosage and
Administration:
Adults, the elderly and children: Apply to each affected area twice a day. The
duration of treatment depends on the clinical response. For external use only.
Contraindications,
Warnings, etc:
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.
Precautions:
May cause irritation if applied to broken or inflamed skin.
Interactions:
None
known.
Pregnancy and lactation:
No clinical data on exposed pregnancies are available. Animal
studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/
foetal development, parturition or postnatal development. There are no specific restrictions
concerning its use during pregnancy, but it is not to be used on the breasts immediately
prior to breast feeding during lactation. Ability to drive and use machines: None.
Adverse
Effects:
Balneum Plus Cream has been reported to cause a burning sensation, erythema, pruritus
or the formation of pustules, aggravation of eczema if applied to inflamed skin areas. Contact
allergy has also been reported.
Legal Category:
GSL.
Marketing Authorisation Number(s):
PL
33016/0010.
NHS Cost:
(excluding VAT). Tube containing 100g – £3.29. Pump pack containing
500g – £14.99.
Marketing Authorisation Holder:
Almirall Hermal GmbH, Scholtzstrasse 3,
21465 Reinbek, Germany.
Further information is available from:
Almirall Limited, 1 The Square,
Stockley Park, Uxbridge, Middlesex, UB11 1TD, UK. Tel: (0) 207 160 2500. Fax: (0) 208 7563 888.
Email:
Date of Revision:
10/2012.
Item code:
UKSOY1402.
Urea 5% and ceramide NP
Urea 5% and lauromacrogols 3%
CARING FOR OLDER SKIN
Ageing skin suffers from decreased lipids, urea, ceramides and lactic acid compared to younger skin.
1–4
BALNEUM OFFERS
TWO SOLUTIONS
RELIEVES
&
REHYDRATES
ITCH RELIEVER
Rapid relief within 5 minutes
5
Well tolerated treatment
6,7
Reduces poly-pharmacy
and topical steroid use by up to 74%
7
REHYDRATES
&
RESTORES
DRY SKIN RESTORER
Once daily can provide
24hr
skin hydration
8,9
Improves skin barrier function
and skin integrity
8
Once daily can offer a time saving
and cost-effective treatment
10
REFERENCES
1.
Harding C, Bartolone J, Rawlings A. Effects of Natural Moisturizing Factor and Lactic Acid Isomers on Skin Function. In: Dry skin and Moisturizers: Chemistry and Function (Loden M, Maibach H, eds).
Boca Raton: CRC Press, 2000:229–41.
2.
Seyfarth F, Schliemann S, Antonov D, Elsner P. Dry skin, barrier function, and irritant contact dermatitis in the elderly.
Clinics in Dermatology
2011;
29
:31–6.
3.
Stamatas GN, Nikolovski J, Mack MC, Kollias N. Infant skin physiology and development during first years of life: a review of recent findings based on in vivo studies.
Int J Cosmet Sci
2011;
33
:17–24.
4.
Cork M, Danby S. Skin barrier breakdown: a renaissance in emollient therapy.
British Journal of Nursing
2009;
18
(14):872–877.
5.
Kunzel J, Walter B,
et al.
How Effective is local Treatment in Acute Itch? Third
International Workshop for the Study of Itch held in Heidelberg, Germany September 25–27 2005.
6.
Balneum Plus Cream. Summary of Product Characteristics September 2012.
7.
Schommer (2007) ‘Efficacy of a
polidocanol-urea combination in dry itchy skin’. Presented at EADV in Vienna 2007; Centre of Dermatology Research: Poster.
8.
Brown K, Higgs-Bayliss T, Chittock J, Cork MJ & Danbu SG. The effect of an emollient
cream containing 5% urea on the biophysical properties of aged skin. Poster 2013; Presented at European Epidermal Barrier Research Network: 1.
9.
Almirall. Data on File BAL01.
10.
MIMS September 2014.
UKSOY2999
February 2015
