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Alliance Pharmaceuticals Ireland
United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Telephone: + 44 (0)1249 466966
Fax: +44 (0)1249 466 977
Medical Information e-mail: medinfo@alliancepharma.co.uk


Summary of Product Characteristics last updated on medicines.ie: 14/09/2010
SPC Hydromol Emollient



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1. NAME OF THE MEDICINAL PRODUCT

Hydromol Bath & Shower Emollient


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Light Liquid Paraffin

37.80% w/w

Isopropyl Myristate

13.00% w/w

Iso-octyl Stearate

15.95% w/w

Laureth 3

11.25% w/w

Macrogol-7 Glycerol Cocoate

22.00% w/w

There is no pharmacologically active ingredient.


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3. PHARMACEUTICAL FORM

Bath additive

Clear, colourless water-dispersible bath oil resulting in an emulsion of dispersed oils together with an homogenised film on the water surface.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

As an aid in the management of dry skin conditions such as eczema, ichthyosis and senile pruritus.


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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:

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:

Pour a small quantity on to a wet sponge or flannel and rub onto wet skin. Rinse and pat dry.


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4.3 Contraindications

Known sensitivity to any of the ingredients.


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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.


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4.5 Interaction with other medicinal products and other forms of interaction

None known.


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4.6 Pregnancy and lactation

Hydromol Bath & Shower Emollient is not contra-indicated in pregnancy or lactation.


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4.7 Effects on ability to drive and use machines

Not applicable.


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4.8 Undesirable effects

Patients should be advised to take care to avoid slipping in the bath.


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4.9 Overdose

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


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5. PHARMACOLOGICAL PROPERTIES

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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.


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5.2 Pharmacokinetic properties

Not applicable.


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5.3 Preclinical safety data

None stated.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Light Liquid Paraffin

Isopropyl Myristate

Iso-octyl Stearate

Laureth 3

Macrogol-7 Glycerol Cocoate


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

Do not store above 25°C


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6.5 Nature and contents of container

Hydromol Bath & Shower Emollient is packed in printed polyethylene bottles of 150ml, 350ml, 500ml and 1 litre capacity.

Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

Alliance Pharmaceuticals Limited

Avonbridge House

Bath Road

Chippenham

Wiltshire

SN15 2BB

United Kingdom


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8. MARKETING AUTHORISATION NUMBER(S)

PA 943/14/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 17 June 2001

Date of last renewal: 17 June 2006


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10. DATE OF REVISION OF THE TEXT

August 2010



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