Odour Free Lloyds Cream (Thornton & Ross Ltd)

1. Name Of The Medicinal Product

Odour Free Lloyds Cream

2. Qualitative And Quantitative Composition

Diethylamine salicylate BP 10%w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

As an analgesic massage cream for the relief of rheumatic pains. For the relief of pain and fibrositis or soft tissue rheumatism, lumbago, sciatica and allied complaints. For the relief of inflammatory pains in muscles, ligaments, joints and sprains, caused by injury or over-use and stiffness after exercise.

4.2 Posology And Method Of Administration

For topical administration

Apply sufficient cream to the painful area, massaging until the cream has been fully absorbed into the skin. The application may be repeated two or three times a day.

The Elderly

No special precautions are required for the elderly.

Children

Should be used in children under the age of six only on medical advice.

4.3 Contraindications

Odour Free Lloyds Cream is contraindicated where there is known sensitivity to aspirin or other salicylates. The cream should not be used on cut, abraded or broken skin.

4.4 Special Warnings And Precautions For Use

Odour Free Lloyds Cream should be kept out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

This product contains a salicylate, which is related to aspirin. There is clinical and epidemiological evidence of the safety of aspirin in human pregnancy. Small amounts of salicylate may be absorbed percutaneously but the amounts excreted in breast milk will be negligible.

4.7 Effects On Ability To Drive And Use Machines

None known

4.8 Undesirable Effects

None known

4.9 Overdose

Adverse systemic effects are unlikely even after accidental oral ingestion. No special measures are necessary.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Diethylamine salicylate is a counter-irritant.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

None state.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Technical white oil, cetostearyl alcohol, stearic acid flake, polysorbate 60, sorbitan monostearate BP, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, purified water Ph.Eur.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months unopened

6.4 Special Precautions For Storage

Store in a cool place

6.5 Nature And Contents Of Container

100g amber glass jar with aluminium screw cap fitted with a PVC closure ring.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0059

9. Date Of First Authorisation/Renewal Of The Authorisation

15 January 2003

10. Date Of Revision Of The Text

01/12/2010