Pain Relief Balm

1. Name Of The Medicinal Product

Pain Relief Balm or PR Heat Rub or Boots Pain Relief Heat Rub

2. Qualitative And Quantitative Composition

Active ingredient
Glycol Monosalicylate	7.5% w/w
Ethyl Nicotinate	1.0% w/w
Nonylic Acid Vanillylamide	0.012% w/w

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic relief of muscular pain and stiffness, including simple backache, sciatica, lumbago, fibrositis, rheumatic pain and the muscular aches and joint stiffness following exercise.

4.2 Posology And Method Of Administration

ADULTS AND CHILDREN OVER 12 YEARS:

Apply the cream to the affected area and massage gently until it is absorbed by the skin. Repeat as required.

CHILDREN UNDER 12 YEARS: Not recommended.

For topical use only.

4.3 Contraindications

Hypersensitivity to any of the ingredients. Known hypersensitivity reactions (eg: asthma, rhinitis, urticaria) in response to any other non-steroidal anti-inflammatory drugs (including when taken orally). Not to be applied to broken skin or to come into contact with the eyes or other sensitive parts of the body.

4.4 Special Warnings And Precautions For Use

For external use only.

If symptoms persist, consult your doctor.

Not recommended for children under 12 years.

Caution: Do not apply the cream to broken skin or allow to come into contact with the eyes and other sensitive areas of the body.

Not for use with occlusive dressing.

Wash hands after use.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of this product during pregnancy and lactation has not been established but use during these periods is unlikely to constitute a hazard.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Occasional hypersensitivity and irritant reactions. May in some individuals give rise to excessive reddening of the skin and feeling of warmth.

4.9 Overdose

Excessive application to the skin may cause excessive reddening and warming . The excess should be removed and the area washed with soap and cold water. Treatment need only be symptomatic. If accidentally ingested, treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Glycol monosalicylate has local analgesic activity by virtue of its counter-irritant and rubefacient properties.

Ethyl nicotinate is a vasodilator with rubefacient properties.

Nonylic acid vanillylamide has rubefacient properties.

5.2 Pharmacokinetic Properties

None stated.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lecithin P Centrolex, propylene glycol, methyl hydroxybenzoate, disodium edetate, cetyl alcohol, silicone fluid F111/20, propyl hydroxybenzoate, purified water, sodium lauryl sulphate, benzyl salicylate.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

18 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

A 35g internally lacquered collapsible aluminium tube with latex welt in a cardboard carton.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 0014/5217R

9. Date Of First Authorisation/Renewal Of The Authorisation

7 November 1984 / 19 September 2001

10. Date Of Revision Of The Text

March 2004