Section 1 should now read:
Pentrax 4.3% w/v Shampoo
Section 2 should now read:
Fractar 5 7.71%
(equivalent to coal tar 4.3% w/v)
For excipients, see Section 6.1
Section 3 should now read:
A burgundy-brown liquid of medium viscosity and a coal-tar odour.
Section 4.6 should now read:
The safety of Pentrax has not been established.
Section 4.8 should now read:
There have been no reports of adverse effects following the use of Pentrax Shampoo. However, coal tar may cause irritation to the skin. Erythema and hypersensitivity to coal tar has been reported. Although carcinogenicity of coal tar has been demonstrated in animal studies, no studies demonstrating an increased risk to skin cancer with normal therapeutic use in humans have been reported. There is no unequivocal evidence to link the use of topically applied coal tar products, with skin cancer
Section 6.4 should now read:
Do not store above 30ºC.
Section 6.6 should now read:
No special requirements.
Section 10 should now read:
December 2005
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