Hydromol Bath & Shower Emollient
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Hydromol Bath & Shower Emollient 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Light Liquid Paraffin BP 37.80% Isopropyl Myristate BP 13.00%
3 PHARMACEUTICAL FORM
Hydromol Bath & Shower Emollient is a clear, colourless bath additive.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of dry skin conditions such as eczema, ichthyosis and senile pruritus.
4.2 Posology and method of administration
Route of administration
Hydromol Bath & Shower Emollient should be used topically and is either added to water or applied to wet skin.
1. For use in the bath
a) Adults/Children and the Elderly:
Add 1—3 inner capfuls to an 8 inch bath of water. Soak for 10-15 minutes.
b) Infants:
Add / to 2 inner capfuls to a small bath of water.
2. For application to the skin as a sponge bath or in the shower.
Adults and Children and the Elderly:
Pour a small quantity on to a wet sponge or flannel and rub onto wet skin. Rinse and pat dry.
Contraindications
4.3
Known sensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Keep away from eyes. Take care to avoid slipping in the bath/shower. If there is aggravation of the condition consult the doctor.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Pregnancy and lactation
Hydromol Bath & Shower Emollient is not contra-indicated in pregnancy or lactation.
4.7 Effects on ability to drive and use machines
Not applicable.
4.8 Undesirable effects
Patients should be advised to take care to avoid slipping in the bath 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 at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Not applicable. Hydromol Bath & Shower Emollient is for topical use only.
5 PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
5.1
The combination of oils used in Hydromol Bath & Shower Emollient are deposited on the skin surface during bathing and thus reduce moisture loss, provide anti-pruritic action, lubricate and soften the skin.
Hydromol Bath & Shower Emollient is particularly suitable for infant bathing. The preparation can also be used as a cleanser where soaps are best avoided.
5.2 Pharmacokinetic properties
Hydromol Bath & Shower Emollient is a water-dispersible bath additive resulting in an emulsion of dispersed oils together with a homogenised film on the surface.
5.3 Preclinical safety data
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
C12-C14 Alcohol with 3 molecules of Ethylene Oxide, Polyol Fatty Acid Ester, Isooctyl Stearate.
6.2 Incompatibilities
Not applicable. Hydromol Bath & Shower Emollient is for topical use only.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Hydromol Bath & Shower Emollient should be stored in a dry place avoiding extremes of temperature ie above 30°C or below 5°C.
6.5 Nature and contents of container
Hydromol Bath & Shower Emollient is packed in polyethylene bottles of 25 ml, 50 ml, 150 ml, 200 ml, 350 ml, 500 ml and 1 litre capacity.
6.6 Special precautions for disposal
Hydromol Bath & Shower Emollient should be used topically and is either added to water or applied to wet skin.
1. For use in the bath
a) Adults/Children and the Elderly:
Add 1—3 inner capfuls to an 8 inch bath of water. Soak for 10-15 minutes.
b) Infants:
Add / to 2 inner capfuls to a small bath of water.
2. For application to the skin as a sponge bath or in the shower.
Adults and Children and the Elderly:
Pour a small quantity on to a wet sponge or flannel and rub onto wet skin. Rinse and pat dry.
7. MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Ltd.,
Avonbridge House,
Bath Road,
Chippenham,
Wiltshire,
SN15 2BB.
8. MARKETING AUTHORISATION NUMBER
PL 16853/0090
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29 June 2004 / 08 June 2007
10 DATE OF REVISION OF THE TEXT
27/05/2015