Hydromol Bath & Shower Emollient

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 capfuls to an 8 inch bath of water. Soak for 10-15 minutes.

b) Infants:

Add ½ 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 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.

4.9 Overdose

Not applicable. Hydromol Bath & Shower Emollient is for topical use only.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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, Iso-octyl 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 printed 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 And Other Handling

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 capfuls to an 8 inch bath of water. Soak for 10-15 minutes.

b) Infants:

Add ½ 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

Alliance Pharmaceuticals Ltd., Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB.

8. Marketing Authorisation Number(S)

PL 16853/0090.

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th June 2004

10. Date Of Revision Of The Text

3^rd November 2009