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1. Name Of The Medicinal Product
HYDROMOL EMOLLIENT
2. Qualitative And Quantitative Composition
Light Liquid Paraffin BP 37.80% w/w
Isopropyl Myristate BP 13.00% w/w
3. Pharmaceutical Form
Hydromol 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 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 capfuls to an 8 inch bath of water. Soak for 10-15 minutes.
b) Infants:
Add ? to 2 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.
4.3 Contraindications
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 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.
4.9 Overdose
Not applicable. Hydromol Emollient is for topical use only.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The combination of oils used in Hydromol Emollient are deposited on the skin surface during bathing and thus reduce moisture loss, provide anti-pruritic action, lubricate and soften the skin.
Hydromol 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 Emollient is a water-dispersible bath additive resulting in an emulsion of dispersed oils together with an 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, Iso-octyl Stearate.
6.2 Incompatibilities
Not applicable. Hydromol Emollient is for topical use only.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Hydromol 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 Emollient is packed in printed polyethylene bottles of 25 ml, 150 ml, 200 ml, 350 ml and 1 litre capacity.
6.6 Special Precautions For Disposal And Other Handling
Hydromol 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 capfuls to an 8 inch bath of water. Soak for 10-15 minutes.
b) Infants:
Add ? to 2 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
Adams Healthcare
Lotherton Way
Garforth
Leeds LS25 2JY
United Kingdom
8. Marketing Authorisation Number(S)
PL 16108/0043
9. Date Of First Authorisation/Renewal Of The Authorisation
31 August 2001
10. Date Of Revision Of The Text
Hydromol Emollient
.
