Quinoderm Cream 5 ()

1. Name Of The Medicinal Product

QUINODERM CREAM 5

2. Qualitative And Quantitative Composition

Benzoyl Peroxide BP 5.0%

Potassium Hydroxyquinoline Sulphate BP 0.5%

3. Pharmaceutical Form

Quinoderm Cream 5 is a creamy white astringent vanishing cream.

It is intended for topical use only.

4. Clinical Particulars

4.1 Therapeutic Indications

Acne vulgaris, acneform eruptions, folliculitis.

4.2 Posology And Method Of Administration

Route of administration

For topical use only.

Adults, children and the elderly:

By gentle massage over all the affected area two or three times daily.

4.3 Contraindications

Acne rosacea. Patients with known sensitivity to either of the active ingredients should not use Quinoderm Cream 5.

4.4 Special Warnings And Precautions For Use

Contact with mouth and eyes should be avoided. Care should be taken to avoid contact with dyed fabrics as this product may adversely dye fastness.

In a few isolated cases, overreaction to Quinoderm Cream 5 may occur. To minimise this possibility, select a small area of skin behind the ear, apply the cream and leave for twelve hours. If severe irritation or pronounced redness occurs, do not proceed with treatment.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Benzoyl Peroxide is an oxidising agent. Hence, Quinoderm Cream 5 should not be used at the same time as other topical agents which would react with an oxidising agent.

4.6 Pregnancy And Lactation

Quinoderm Cream 5 is not contra-indicated in pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Not applicable.

4.8 Undesirable Effects

Not applicable.

4.9 Overdose

Not applicable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The combination of the mild keratolytic properties of benzoyl peroxide and the antibacterial and antifungal properties of potassium hydroxyquinoline sulphate in a specially formulated bland water-miscible base make this preparation valuable in the treatment of acne vulgaris, acneform eruptions and folliculitis.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactic Acid BP, White Soft Paraffin B P, Edetic Acid B.P., Sodium Acid Phosphate BP, Maize Starch BP, Cetyl Stearyl Alcohol, Sodium Cetyl Sterayl Sulphate, P.E.G. 40 Castor Oil, Purified Water BP.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three Years.

6.4 Special Precautions For Storage

Quinoderm Cream 5 should not be stored above 25 degrees centigrade. Quinoderm Cream 5 should not be refrigerated.

6.5 Nature And Contents Of Container

Quinoderm Cream 5 is available in heat sealed low density polyethylene tubes with flush fitting cap containing 50g of product. Each tube is cartoned and contains a patient information leaflet.

6.6 Special Precautions For Disposal And Other Handling

For topical use only.

7. Marketing Authorisation Holder

Quinoderm Limited

Manchester Road

Hollinwood

OLDHAM, UK

OL8 4PB

8. Marketing Authorisation Number(S)

0291/0012

9. Date Of First Authorisation/Renewal Of The Authorisation

26/9/84

10. Date Of Revision Of The Text

June 2001

Legal Category

P