| Section 1: ammended so that now it states anthisan bite and sting 2% w/w cream
Section 2: amended to also state other excipients, now reads:
Mepyramine Maleate 2% w/w
Also contains:
Castor oil 23,60% w/w
Ceto-stearyl alcohol 13,80% w/w
Propylene glycol 600 monostearate 4,90% w/w
Methyl hydroxybenzoate 0,20% w/w
For a full list of excipients, see section 6.1
Section 3: changed to be more specific, now states ‘A smooth off-white cream’
Section 4.3- following text added: Hypersensitivity to the active substance or to any of the excipients.
Section 4.7: following text added: Anthisan Bite and Sting Cream has minor or moderate influence on the ability to drive and use machines.
Section 5.1- ATC code deleted
Section 6.1- re-formatted
Section 6.3- shelf life has not changed- just amended to read 3 years rather than 36 months
Section 6.4- wording changed so that it now reads store below 30 degrees rather than do not store above 30 degrees- advise remains the same
Section 6.5- slight change to make it clear that the tube has a screw cap
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