Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Balneum Bath Oil
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Soya oil may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Balneum is a bath additive that contains soya oil and is used for the treatment of dry skin disorders such as eczema and dermatitis. Balneum relieves symptoms associated with dry skin whilst also cleansing, and helping to protect against further drying. Soya oil is an emollient (moisturiser) which soothes and softens dry skin by helping to replace lost oils. The oil forms tiny droplets in the water which leave a thin film on your skin. This film helps to stop your skin from drying out and so makes it feel soft. 2.
What you need to know before you take it
e Balneum
Do not use Balneum
- If you are allergic (hypersensitive) to soya, peanut or any of the other ingredients of this medicine (listed in section 6)
- If you suffer from fresh pustular forms of Psoriasis (Psoriasis pustulosa). All full baths – including those to which Balneum has been added – should only be taken after consultation with your doctor in the following cases: major skin injuries, acute skin diseases of unknown cause, feverish and infectious diseases, heart failure and high blood pressure. If the above applies to you, do not use this medicine and talk to your doctor. Warnings and precautions
- Avoid getting Balneum in your eyes, however, if this should occur, rinse immediately with clean water. If eye irritation remains please see your doctor.
1/4
• • • • •
Undiluted Balneum should not be swallowed. If this happens talk to your doctor or pharmacist immediately. Make sure water does not exceed 36°C, as this can make your skin condition worse. Take care not to slip in the bath. Always clean the bath immediately after you have used Balneum. To do this rinse thoroughly with hot water and then clean with a household cleaner. If your symptoms do not get better, go and see your doctor.
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 may reduce product build-up but not totally remove it. Other medicines and Balneum There are no known interactions when using Balneum with other medicines but please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not use soaps or syndet in addition to Balneum as this neutralises the effect of the product. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. You may use Balneum whilst you are pregnant.
Driving and using machines Balneum is not expected to have any effect on your ability to drive or use machines. Balneum contains butylhydroxytoluene and fragrance containing allergens Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes. This medicine contains fragrance with allergens. These allergens (d-limonene, linalool) may cause allergic reactions.
How to take it
Balneum Always use Balneum exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. •
Balneum is for external use by patients of all ages.
•
Pour the appropriate amount of Balneum liquid into the bath as the bath is filling (please see below for correct measurements), be careful the water is not too hot.
•
Stay in the bath for at least 10 minutes but not longer than 20 minutes.
•
In the case of infants and small children a bath of only a few minutes is mostly sufficient.
•
Do not use soap since this will remove Balneum from your skin and can also dry the skin.
2/4
•
If only a small area of skin is affected, you may be able to bathe the affected area in a bowl or sink.
Measurements:
- For a full bath (Adults dose) – 1 capful (about 20 ml)
- For a child's or baby's bath – 1⁄4 of a capful (about 5 ml)
- For a partial bath in a bowl or sink – 1/8 of a capful (about 2.5 ml) If you have very dry skin, you can use two or three times the above amounts. •
After bathing gently pat dry with a towel. If you wipe or rub your skin too much the Balneum will not work as well.
•
Adults and children should bathe with Balneum 2 to 3 times a week or as often as required. Your doctor will advise you how often you should use Balneum depending on how severe your skin condition is. For babies and infants a daily bath is recommended.
Always clean the bath immediately after you have used Balneum. To do this, rinse the bath and equipment thoroughly with hot water and then clean with a household cleaner. Duration of treatment Your doctor will tell you for how long you need to use Balneum. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you use more Balneum than you should There are no known harmful effects resulting from excessive oil concentrations in the bath water.
4.
Possible side effects
Like all medicines, Balneum can cause side effects, although not everybody gets them. • •
Very rarely during use there may be cases of reddening, itching and burning. In very rare cases soya oil may cause allergic reactions.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can also provide more information on the safety of this medicine. 5.
How to store it
Balneum
Keep out of the sight and reach of children. Do not use Balneum after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
3/4
You should store Balneum in its original pack. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.
Content of the pack and other information
What Balneum contains The active substance is soya oil 84,75% . Other ingredients: Polyoxyethylene lauryl ether, oleic acid, diethanolamide, perfume oil (d-limonene, linalool), propylene glycol(E1520), butylhydroxytoluene (E321), ascorbyl palmitate and citric acid monohydrate. What Balneum looks like and content of the pack Balneum is an oily liquid.
Your medicinal product comes in either 20 ml, 95 ml, 100 ml, 150 ml, 200 ml, 225 ml, 250 ml, 300 ml, 500 ml, 2x500ml, 600 ml or 1000 ml high density polyethylene bottles with a screw cap and also in 10 ml and 20 ml foil laminate sachets and 20 ml polyethylene/foil blisters. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Almirall Hermal GmbH Scholtzstraße 3, 21465 Reinbek, Germany Tel.: +49-40 727 04-0 Fax: +49-40 722 92 96 Manufacturer Almirall Hermal GmbH Scholtzstraße 3, 21465 Reinbek, Germany Industrias Farmaceuticas Almirall, S.A. Ctra. de Martorell 41-61, 08740 Sant Andreu de la Barca, Barcelona, Spain. This leaflet was last revised in: 10/2021
OTHER INFORMATION Self Help Measures Eczema and dermatitis have many different causes and there are various self help measures you can adopt. If you want to find out more, you may find the following organisation helpful: National Eczema Society
11 Murray Street London NW1 9RE Telephone Number: 020 7281 3553
4/4
Frequently asked questions about Balneum Bath Oil
What is the active substance in Balneum Bath Oil?
The active substance in Balneum Bath Oil is soya oil.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Balneum Bath Oil, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Balneum Bath Oil without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: soya oil
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Dry skin conditions including those associated with dermatitis and eczema.
4.2. Posology and method of administration
Bath additive
The liquid should be added to bath water and thoroughly mixed until evenly distributed
For full bath (approx. 100 litres)
20ml (1 measure)
For child's bath (approx. 25 litres)
5ml (1/4 measure)
For partial bath (approx. 5 litres)
2.5ml (1/8 measure)
In particularly dry skin, 2-3 times the above quantities can be used. Generally, 2-3 baths should be taken weekly. For babies and infants a daily bath is recommended.
The temperature of the bath water should not exceed 36 °C as the re-greasing effect is diminished at higher temperatures.
For the treatment of pruritus the temperature should be 32 °C or as low as can be tolerated.
The bath should not be longer than 20 minutes. In the case of infants and small children a bath of only a few minutes is mostly sufficient.
The duration of the therapy depends on the course of the disease. The instructions in the section 4.4 “Special warnings and precautions for use” should be taken into account.
4.3. Contraindications
• hypersensitivity to the active ingredient or to any of the excipients listed in section 6.1.
• hypersensitivity to peanut or soya
• fresh pustular forms of psoriasis (Psoriasis pustulosa).
In cases of
• major injuries to the skin and acute skin diseases of unknown cause,
• severe febrile and infectious diseases,
• cardiac muscle weakness (cardiac insufficiency),
• high blood pressure (hypertension)
full baths should only be taken - irrespective of the ingredients - after consultation with a doctor.
4.4. Special warnings and precautions for use
Do not apply in the area of the eyes. In cases of accidental contact with the eyes rinse out immediately with copious amounts of cold water. Consult an ophthalmologist if irritation continues.
Butyl hydroxytoluene may cause local skin reactions (e.g. contact dermatitis), irritations of the eyes and mucous membranes.
This medicine contains fragrance with allergens. These allergens (d-limonene, linalool) may cause allergic reactions.
There is an increased risk of slipping due to the oil film on the skin and the oil film in the bath or shower.
The bathtub, shower and children's bathtub (if applicable) should be cleaned immediately after every bath using conventional household detergent and then rinsed out with hot water.
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
The additional use of soaps or syndets neutralises the effect of Balneum.
4.6. Fertility, pregnancy and lactation
There are no known restrictions with respect to use during pregnancy and the lactation period.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Undesirable effects
The data given for frequency of adverse reactions is based on the following categories:
Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to 1/1,000)
Very rare (< 1/10,000)
Not known (frequency based on available data not assessable)
Skin and subcutaneous tissue disorders:
During the use of Balneum there may be very rare cases of reddening, itching and burning.
Immune system disorders:
Soya oil may cause allergic reactions in very rare cases (<1/10,000).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
There are no known harmful effects resulting from excessive oil concentrations in the bath water.
💬 Ask about this leaflet
Ask anything about Balneum Bath Oil. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.