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FIERY JACK OINTMENT

Active substance(s): CAPSICUM OLEORESIN

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Fiery Jack Ointment

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Oleoresin Capsicum 2.466 % w/w
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Ointment

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
To be applied once or twice daily and only to a limited area of skin over the
painful lesion.
Not recommended for children under 12 years.

4.3

Contraindications
Not to be used by people with delicate, sensitive, diseased skin or known
hypersensitivity to any of the ingredients.

4.4

Special warnings and precautions for use
Care should be taken to avoid sensitive parts of the body and to thoroughly
wash hands after each application.
For external use only.
Keep out of reach of children.
Consult a doctor if pain persists. (Packaging only)
Fiery Jack Ointment contains Arachis oil (peanut oil) and should not be
taken/applied by patients known to be allergic to peanut. As there is a possible
relationship between allergy to peanut and allergy to Soya, patients with Soya
allergy should also avoid Fiery Jack Ointment.

4.5

Interaction with other medicinal products and other forms of interaction
No significant interactions have been reported.

4.6

Fertility, Pregnancy and lactation
There is no, or inadequate evidence of safety in human pregnancy. Use in
pregnancy only when there is no safer alternative.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
No significant other undesirable effects have been reported.

4.9

Overdose
When used externally as directed, overdose is unlikely.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Capsicum is mainly used externally as a counter irritant. The Oleoresin is
very irritant. The active ingredient Capsaicin has local analgesic properties.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Yellow Soft Paraffin
Hard Paraffin Wax
Arachis Oil
Lard

6.2

Incompatibilities
None known.

6.3

Shelf life
36 months.

6.4

Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.

6.5

Nature and contents of container
Slip lid tins containing 32gm.

6.6

Special precautions for disposal
Not applicable

7

MARKETING AUTHORISATION HOLDER
Optima Consumer Health Ltd
Concept house,
Brackenbeck Road,
Bradford,
BD7 2LW,
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 40575/0005

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/09/2005

10

DATE OF REVISION OF THE TEXT
17/09/2012

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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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