Quinoderm Lotio-Gel 5%

1. Name Of The Medicinal Product

QUINODERM™ LOTIO-GEL 5%

2. Qualitative And Quantitative Composition

Benzoyl Peroxide BP	5.0%
Potassium Hydroxyquinoline Sulphate BP	0.5%

3. Pharmaceutical Form

Quinoderm Lotio-gel 5% is a homogeneous astringent gel formulated to give the colour and consistency of a creamy white lotion. It is intended for topical use only.

4. Clinical Particulars

4.1 Therapeutic Indications

Acne

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 one to three times daily.

4.3 Contraindications

Patients with known sensitivity to either of the active constituents should not use Quinoderm Lotio-gel 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 affect dye fastness.

In a few isolated cases, overreaction to Quinoderm Lotio-gel 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 Lotio-gel 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 Lotio-gel 5% is not contra-indicated in pregnancy or lactation.

4.7 Effects on ability to drive and use machine

Not applicable.

4.8 Undesirable Effects

If symptoms persist or if the condition worsens or if irritation, itch or rash occurs, treatment should be discontinued and the Physician or Pharmacist consulted for advice.

4.9 Overdose

If accidentally ingested symptomatic and supportive management is advised.

5. Pharmacological Properties

The main pharmacological action of benzoyl peroxide is considered to be keratolytic and comedolytic. Potassium hydroxyquinoline sulphate has broad spectrum antibacterial activity. This combination is formulated in a specifically researched and developed base and is designed to aid the resolution of the polymorphic lesions of acne.

The base has been developed with the objective of providing a stable pharmaceutical form which maximises the advantages of a gel and lotion in a system which does not employ organic solvents and therefore has a correspondingly lower irritancy, toxicity and abuse potential.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Light Liquid Paraffin BP, Edetic Acid BP, Sodium Acid Phosphate BP, Maize Starch BP, Lactic Acid BP, Cetomacrogol 1000 BP, cetyl stearyl alcohol, sodium cetyl stearyl sulphate, PEG 40 castor oil, Purified Water BP.

6.2 Incompatibilities

Any topical agent that would react with an oxidising agent.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Quinoderm Lotio-gel 5% should be stored in a cool, dry place avoiding extremes of temperature, i.e. not less than 5°C and not more than 30°C.

6.5 Nature And Contents Of Container

Quinoderm Lotio-gel 5% is available in polyethylene bottles with a flip-top cap containing 30 ml of product. Each bottles is cartoned and contains a package insert.

6.6 Special Precautions For Disposal And Other Handling

By gentle massage over all the affected area one to three times daily.

8. Marketing Authorisation Number(S)

0291/0009

10. Date Of Revision Of The Text

September 1995.

Legal category

P.