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1. Name Of The Medicinal Product
Polytar Liquid
2. Qualitative And Quantitative Composition
Tar Blend 1% w/w
Tar Blend comprises:
Pine tar, Cade Oil, Coal Tar Solution, Arachis Oil extract of Coal Tar.
3. Pharmaceutical Form
Medicated Shampoo
4. Clinical Particulars
4.1 Therapeutic Indications
Polytar Liquid is indicated in the treatment of scalp disorders including psoriasis, dandruff, seborrhoea, eczema and pruritus. Polytar Liquid is also of value in the removal of ointments and pastes used in the treatment of psoriasis.
4.2 Posology And Method Of Administration
The hair should be wetted and sufficient Polytar Liquid applied to produce an abundant lather. The scalp and adjacent areas should be vigorously massaged with the fingertips. The hair should then be thoroughly rinsed and the procedure repeated.
Polytar Liquid should be used once or twice weekly.
4.3 Contraindications
Patients with a known hypersensitivity to any of the ingredients should not use the product.
4.4 Special Warnings And Precautions For Use
Polytar Liquid contains arachis oil (peanut oil) and should not be used 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 Polytar Liquid.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
There are no known interactions with other medicaments or other forms of interaction.
4.6 Pregnancy And Lactation
There is no, or inadequate evidence of the safety of Polytar Liquid in human pregnancy and lactation, but it has been in wide use for many years without apparent ill consequence.
4.7 Effects On Ability To Drive And Use Machines
The use of this product will not affect the ability to drive and to use machines.
4.8 Undesirable Effects
Tar products may cause skin irritation, rashes and rarely, photosensitivity. If irritation occurs and persists, treatment should be discontinued.
4.9 Overdose
The product is intended for external use only. It is applied to the scalp and rinsed off. Use of an excessive quantity is not a cause for concern.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Tars suppress DNA synthesis in hyperplastic skin, inhibiting mitotic activity and protein synthesis. They decrease epidermal proliferation and dermal infiltration and thus promote a return to normal keratinisation.
Tars also have vasoconstrictor, antipruritic and antiseptic properties.
5.2 Pharmacokinetic Properties
The product is applied topically and acts at the site of application. The potential for systemic absorption from a wash off shampoo is extremely low.
5.3 Preclinical Safety Data
Tar preparations have been in widespread use for many years and their safety in humans has been established.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Oleyl alcohol
Coconut diethanolamide
Hexylene glycol
Polysorbate 80
Triethanolamide Lauryl Sulphate
Sodium chloride
Citric acid
Octylphenoxypolyethoxy ethanol
Imidurea
Fragrance 5412
Purified Water
6.2 Incompatibilities
There are no known incompatibilities
6.3 Shelf Life
a) For the product as packaged for sale
3 years
b) After first opening the container
Comply with expiry date
6.4 Special Precautions For Storage
There are no special precautions for storage.
6.5 Nature And Contents Of Container
High density polyethylene bottles of 65ml, 150ml, 200ml, 250ml, 350ml, 400ml, 500ml, 600ml, 1000ml.
6.6 Special Precautions For Disposal And Other Handling
There are no special instructions for use or handling of Polytar Liquid.
7. Marketing Authorisation Holder
GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Middlesex
TW8 9GS
Trading as Stiefel
Stockley Park West
Uxbridge
Middlesex
UB11 1BT
8. Marketing Authorisation Number(S)
PL 19494/0080
9. Date Of First Authorisation/Renewal Of The Authorisation
14th March 1990/11th May 2000/11th May 2005/27th February 2009
10. Date Of Revision Of The Text
16 March 2011
Polytar Liquid
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