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Goddards Muscle Lotion

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Goddards Muscle Lotion

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Turpentine Oil    BP 22.0% v/v

Dilute Acetic Acid    BP    30.0% v/v

Dilute Ammonia    BP    14.0% v/v

3 PHARMACEUTICAL FORM

Topical Emulsion

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the symptomatic relief of muscular pain and stiffness, including backache, sciatica, lumbago, fibrositis, rheumatic pain and pain caused by bruises, sprains, strains, stiff muscles and unbroken chilblains.

4.2 Posology and method of administration

Once or twice daily. Shake the bottle thoroughly. Pour into palm of hand and rub well until dry.

4.3 Contraindications

None known.

4.4 Special warnings and precautions for use

If symptoms persist, consult your doctor.

Do not use if skin is broken.

For external use only.

Keep all medicines 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

As with all medicines, medical advice should be sought prior to use.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

None known.

4.9


Overdose

Treatment is generally supportive. Emesis should not be induced.

Lavage should not be performed.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Goddard Muscle Lotion is a traditional rub for the symptomatic relief of muscular pain and stiffness.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Arlacel 83V

PEG-8-Oleate Purified Water

6.2


Incompatibilities

None known.

Shelf life

6.3


22 months unopened.

6.4 Special precautions for storage

None.

6.5 Nature and contents of container

Ribbed or non-ribbed, amber or white glass bottle with a plastic cap containing a PVDC/steran faced wad (100 ml or 200 ml).

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Actavis Group PTC ehf Reykjavikurvegi 76-78 220 Hafnarfjordur Iceland.

8    MARKETING AUTHORISATION NUMBER(S)

PL 30306/0078

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/07/2008

10


DATE OF REVISION OF THE TEXT

07/04/2009