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FIERY JACK CREAM

Active substance(s): CAPSICUM OLEORESIN / DIETHYLAMINE SALICYLATE / GLYCOL SALICYLATE / METHYL NICOTINATE / CAPSICUM OLEORESIN / DIETHYLAMINE SALICYLATE / GLYCOL SALICYLATE / METHYL NICOTINATE / CAPSICUM OLEORESIN / DIETHYLAMINE SALICYLATE / GLYCOL SALICYLATE / METHYL NICOTINATE

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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.
analgesic properties.

The active ingredient Capsiacin has local

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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