SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Fiery Jack Cream

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Glycol Salicylate BP 5.00 % w/w, Diethylamine Salicylate BP 5.00 % w/w, Capsicum Oleoresin BPC 1.25 % w/w, Methyl Nicotinate BP 1.00% w/w.

3    PHARMACEUTICAL FORM

Cream.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Symptomatic relief of muscular pain and stiffness including Sciatica, Lumbago, Fibrositis and Rheumatic pain.

4.2 Posology and method of administration

One or two applications per day should suffice to give relief. Not recommended for children under 12 years.

4.3 Contraindications

Not to be used on patients allergic or sensitive to Salicylates. Not to be used on broken skin.

4.4 Special warnings and precautions for use

For external use only.

Consult a Doctor if pain persists.

Keep out of reach of children.

4.5 Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, Pregnancy and lactation

None stated.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

None stated.

4.9 Overdose

None stated.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Glycol Salicylate: is an ingredient of a number of rubifacient creams.

Diethylamine Salicylate: is used topically at concentration of 5 or 10% in creams for rheumatic or muscular pain.

Capsicum Oleoresin: Capsicum is mainly used as an external counter irritant.

The Oleoresin is very irritant. The active ingredient Capsiacin has local analgesic properties.

Methyl Nicotinate: is used in ointments and creams for topical application as a rubifacient for the relief of pain and muscular rheumatism, lumbago and fibrositis.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sebase, Emulsifying Wax, Euxyl K100, Water.

6.2 Incompatibilities

None stated.

6.3 Shelf life

36 months.

6.4 Special precautions for storage

Dry, frost free conditions.

6.5 Nature and contents of container

Aluminium printed tube containing 35gm

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

Optima Consumer Health Limited

Concept house

Brackenbeck road

Bradford

BD7 2LW

United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 40575/0004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/03/2006

10 DATE OF REVISION OF THE TEXT

20/09/2012