Hydromol Cream (Alliance Pharmaceuticals)

1. Name Of The Medicinal Product

Hydromol Cream.

2. Qualitative And Quantitative Composition

Sodium Pyrrolidone Carboxylate 2.5%.

Excipients: Cetomacrogol emulsifying wax contains cetostearyl alcohol.

For full list of excipients see Section 6.1.

3. Pharmaceutical Form

Hydromol Cream is a soft, white, oil-in-water cream which can be massaged easily into the skin.

4. Clinical Particulars

4.1 Therapeutic Indications

Any condition in which “dry skin” is a feature, including all forms of dermatitis/eczema and all degrees of ichthyosis and senile pruritus.

4.2 Posology And Method Of Administration

Route of administration

For topical use only.

Adults, Children and the Elderly:

Apply liberally to the affected area and massage well into the skin. Hydromol Cream may be used as often as required.

Hydromol Cream is especially beneficial when used immediately after washing or bathing, when the resultant warmth of the skin enhances absorption.

4.3 Contraindications

There are no contra-indications except true hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

The formulation is not designed for use as a diluent.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Hydromol Cream is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Rarely a non serious allergic type reaction may be experienced, e.g. rash.

4.9 Overdose

Not applicable. Hydromol Cream is for topical use only.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of oils used in Hydromol Cream helps to lubricate and hydrate the skin. Moisture loss from the stratum corneum is reduced by the formation of an occlusive film by liquid paraffin on the surface of the skin. Isopropyl myristate, a fatty acid ester, is easily absorbed into the skin and helps to improve skin softness.

5.2 Pharmacokinetic Properties

Sodium pyrrolidone carboxylate positively aids the hydration of skin.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid Paraffin

Isopropyl Myristate

Sodium Lactate

Cetomacrogol Emulsifying Wax (contains cetostearyl alcohol)

Myristyl Myristate

Cetomacrogol 1000

Hydroxybenzoates (Parabens)

Phenoxyethanol

Purified Water.

6.2 Incompatibilities

Not applicable. Hydromol Cream is for topical use only.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Hydromol Cream should be stored in a dry place avoiding extremes of temperature ie not less than 5°C and not more than 30°C.

6.5 Nature And Contents Of Container

Hydromol Cream is packed in low density polyethylene tubes of 10 g, 50 g and 100 g with a flush fitting cap. It is also available in polypropylene tubs containing 500 g with pump dispenser.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

7. Marketing Authorisation Holder

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

8. Marketing Authorisation Number(S)

PL 16853/0089.

9. Date Of First Authorisation/Renewal Of The Authorisation

1^st October 2004.

10. Date Of Revision Of The Text

20^th March 2009