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GEORGES AMERICAN LINIMENT

Active substance(s): CAMPHOR OIL SYNTHETIC (NORTHERN) / CAPSICUM / EUCALYPTUS OIL / ROSEMARY OIL / TURPENTINE OIL / CAMPHOR OIL SYNTHETIC (NORTHERN) / CAPSICUM / EUCALYPTUS OIL / ROSEMARY OIL / TURPENTINE OIL / CAMPHOR OIL SYNTHETIC (NORTHERN) / CAPSICUM / EUCALYPTUS OIL / ROSEMARY OIL / T

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
George’s American Liniment

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Eucalyptus Oil BP
Turpentine Oil BP
Capsicum BPC 1973
Rosemary Oil BPC
Camphor, Synthetic, BP

3

2.00% v/v
5.02% v/v
2.47% w/v
0.30% v/v
2.01% w/v

PHARMACEUTICAL FORM
Liquid (Liniment)

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of rheumatic pain, lumbago, sciatica, stiff joints,
backache and cramp.

4.2

Posology and method of administration
For cutaneous use only
.
Adults , elderly, children over 12 years Apply to the affected area up to three
times a day. Do not apply to broken skin.
If symptoms persist or worsen consult a doctor .
Not recommended for use in children under 12 years of age (see section 4.4.
Special warnings and precautions for use’

4.3

Contraindications
Hypersensitivity to any of the active ingredients or the excipients

4.4

Special warnings and precautions for use
Do not exceed the stated dose
For external use only. Do not apply to broken skin or the face.

Avoid contact with the eyes.
If symptoms persist or worsen consult a doctor
If applied directly onto the nostrils of infants CNS overstimulation can occur.
Camphor is highly lipophilic and can accumulate in the body following
prolonged exposure which may result in CNS toxicity.
The use of this product in children or adolescents under 12 years of age is not
recommended because data are not sufficient and medical advice should be
sought.

4.5

Interaction with other medicinal products and other forms of interaction
Not applicable.

4.6

Fertility, Pregnancy and lactation

The safety of the product during pregnancy and lactation has not been
established. In the absence of sufficient data, the use during pregnancy and
lactation is not recommended.

4.7

Effects on ability to drive and use machines
Not applicable.

4.8

Undesirable effects
None known.
If adverse reactions occur a doctor or pharmacist should be consulted

4.9

Overdose
Overdose may result in skin irritation
Monitor for up to 12 hours after suspected ingestion.
Misuse
Swallowing of the product may cause gastrointestinal symptoms like vomiting
and diarrhoea. Treatment is symptomatic.
After accidental consumption of a camphor containing product, acute
poisoning was observed with nausea, vomiting, abdominal pain, headache,
vertigo, feeling hot, flushing, convulsions, respiratory depression and coma.
Recommended treatment is nasogastric suctioning and lavage. Camphorinduced seizures have been successfully treated with benzodiazepines.
Patients with severe gastrointestinal or neurological symptoms should be
observed and treated symptomatically. Do not induce vomiting

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Camphor, synthetic:
Counter-irritant
Oil of Eucalyptus:
Antiseptic and rubefacient
Oil of Rosemary:
Mild irritant
Oil of Terebintli:
Counter-irritant
Capsicum:
Counter-irritant

5.2

Pharmacokinetic properties
No data available.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Industrial methylated spirits BP
Water
Soft soap

86.670% v/v
6.010% v/v
7.914%w/v

6.2

Incompatibilities
None known.

6.3

Shelf life
24 months.

6.4

Special precautions for storage
This medicinal product does not require any special storage conditions

6.5

Nature and contents of container
Liniment contained in white flint glass bottles (75ml and 150ml): 24mm
plastic caps

6.6

Special precautions for disposal
No special instructions for handling.

7

MARKETING AUTHORISATION HOLDER
Hubert A C Thomas & Company
Glyneithin

Burry Port
Carmarthenshire
SA16 0TB

8

MARKETING AUTHORISATION NUMBER(S)
PL 1354/5002R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/06/85 and 26/03/2003

10

DATE OF REVISION OF THE TEXT
21/06/2011

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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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