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Alliance Pharmaceuticals
Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
Telephone: +44 (0)1249 466 966
Fax: +44 (0)1249 466 977
WWW: http://www.alliancepharma.co.uk
Medical Information e-mail: medinfo@alliancepharma.co.uk

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Summary of Product Characteristics last updated on the eMC: 08/03/2012
SPC Hydromol Bath & Shower 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 BP 37.80%

Isopropyl Myristate BP 13.00%


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3. PHARMACEUTICAL FORM

Hydromol Bath & Shower Emollient is a clear, colourless bath additive.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the treatment 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 and the Elderly:

Add 1—3 capfuls (inner capfuls for 500ml or 1 litre pack sizes) to an 8 inch bath of water. Soak for 10-15 minutes.

b) Infants:

Add ½ to 2 capfuls (inner capfuls for 500ml or 1 litre pack sizes) 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.


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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

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.


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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 excipients

C12-C14 Alcohol with 3 molecules of Ethylene Oxide, Polyol Fatty Acid Ester, Iso-octyl Stearate.


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6.2 Incompatibilities

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


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6.3 Shelf life

3 years.


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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.


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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.


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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 (inner capfuls for 500ml or 1 litre pack sizes) to an 8 inch bath of water. Soak for 10-15 minutes.

b) Infants:

Add ½ to 2 capfuls (inner capfuls for 500ml or 1 litre pack sizes) 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.


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7. MARKETING AUTHORISATION HOLDER

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


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8. MARKETING AUTHORISATION NUMBER(S)

PL 16853/0090.


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

29th June 2004


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10. DATE OF REVISION OF THE TEXT

1st September 2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/18945/SPC/


Active Ingredients/Generics

 
  isopropyl myristate
  light liquid paraffin