Alcoderm Cream

1. Name Of The Medicinal Product

Alcoderm Cream

2. Qualitative And Quantitative Composition

None

3. Pharmaceutical Form

Cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Dry, chafed or irritated skin - Alcoderm is indicated in any condition where the moisture content of the horny layer has decreased below the normal level and the skin is no longer soft and pliable.

Also recommended:

a) in acute inflammatory conditions where the skin is intact, such as sunburn and windburn.

b) as a soothing, hydrating agent in certain inflammatory skin conditions where there is dryness and scaling, such as ichthyosis, atopic eczema, winter itch, etc.

4.2 Posology And Method Of Administration

Dosage:

Adults, children and the elderly

Apply topically to the skin as required to alleviate the symptoms of dry, chafed or irritated skin conditions or as directed by a doctor.

Route of Administration:

Apply topically to the skin.

4.3 Contraindications

Hypersensitivity to the constituents of the preparation.

4.4 Special Warnings And Precautions For Use

Avoid contact with eyes.

If symptoms persist consult your physician.

In the rare event of skin reaction, treatment should be discontinued.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None.

4.6 Pregnancy And Lactation

May be used during this period.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Very rarely, a mild skin irritation can occur.

4.9 Overdose

Accidental ingestion is not anticipated to cause any harm to the patient.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Not applicable.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Not relevant as the product has been in use for many years without apparent ill consequence.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Mineral Oil (Liquid Paraffin)

Isopropyl Palmitate Ph. Eur.

Sodium Lauryl Sulphate Ph. Eur.

Methylparaben Ph. Eur.

Propylparaben Ph. Eur.

Sorbitol solution (70%) Ph. Eur.

Cetyl Alcohol Ph. Eur.

Stearyl Alcohol Ph. Eur.

Sorbitan Monostearate Ph. Eur.

Spermaceti (Cetyl Esters Wax) USP/NF

Silicone Fluid (Dimeticone) Ph. Eur.

Perfume (Chemoderm 6435)

Citric Acid Anhydrous Ph. Eur., or Sodium Hydroxide Ph. Eur.

Purified Water Ph. Eur.

6.2 Incompatibilities

None

6.3 Shelf Life

4 years.

6.4 Special Precautions For Storage

Store at room temperature.

6.5 Nature And Contents Of Container

Polyethylene plastic tube with a white polypropylene screw cap as the closure.

Package sizes: 60g.

6.6 Special Precautions For Disposal And Other Handling

Not relevant.

7. Marketing Authorisation Holder

Galderma (UK) Limited,

Galderma House,

Church Lane,

Kings Langley,

Hertfordshire, WD4 8JP,

England.

8. Marketing Authorisation Number(S)

PL 10590/0004

9. Date Of First Authorisation/Renewal Of The Authorisation

21 January 1993

10. Date Of Revision Of The Text

May 2001

11. Legal Status

P - Pharmacy only