1. Name Of The Medicinal Product
White Liniment BP (White Embrocation BP)
2. Qualitative And Quantitative Composition
Turpentine Oil BP 25.0% v/v
3. Pharmaceutical Form
Liniment
4. Clinical Particulars
4.1 Therapeutic Indications
For relief of rheumatism, lumbago, sciatica and sprains.
4.2 Posology And Method Of Administration
Applied directly to the skin.
Apply 2 or 3 times a day, as required. Rub thoroughly into the affected parts.
This product is suitable for use by adults and the elderly but is not recommended for children under 12 years, except under a doctor's instruction.
4.3 Contraindications
Sensitivity to turpentine oil
4.4 Special Warnings And Precautions For Use
For external use only.
Avoid broken or inflamed skin.
Keep all medicines away from children.
Keep away from the eyes and other sensitive areas.
If symptoms persist seek medical advice.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.
4.6 Pregnancy And Lactation
Use of all medicines should be avoided if possible during pregnancy and lactation. No information is available regarding safety of use of this product in the above condition.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
May cause irritation. Absorption of large amounts may cause some of the effects of poisoning with turpentine oil.
4.9 Overdose
In case of accidental ingestion the symptoms will be those of turpentine poisoning, local burning and gastro-intestinal upset, coughing and choking, pulmonary oedema, excitement, coma, fever, tachycardia, liver damage, haematuria and albuminuria.
15ml of turpentine oil may be fatal to children (equivalent to 60ml of white liniment).
The stomach should be emptied by emesis or by aspiration and lavage. Suitable supportive measures should be taken.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Turpentine is applied externally in liniments as a counter-irritant and rubefacient.
5.2 Pharmacokinetic Properties
No information available.
5.3 Preclinical Safety Data
None.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Oleic Acid BP, Ammonium Chloride BP, Ammonia Solution Strong BP, Purified Water BP.
6.2 Incompatibilities
None known.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Store below 25°C.
Do not allow to freeze.
6.5 Nature And Contents Of Container
200ml Plain round amber glass bottle with plastic cap or white 28mm cap with tamper evident band and EPE Saranex liner.
500ml Amber glass winchester bottle with plastic cap or white 28mm cap with tamper evident band and EPE Saranex liner.
6.6 Special Precautions For Disposal And Other Handling
No special requirements.
7. Marketing Authorisation Holder
Thornton and Ross Limited
Linthwaite Laboratories
Huddersfield
HD7 5QH
8. Marketing Authorisation Number(S)
PL 00240/6440R
9. Date Of First Authorisation/Renewal Of The Authorisation
18th May 1998
10. Date Of Revision Of The Text
17/08/2004
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
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