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ARGOM Appendix 5: Guidelines on OTC applications for specific substances
Note: This guidance document contains references to warning statements that are being included in the current updating of the RASML document. Warning statements marked with an (*) which are included in the updated version of the RASML document will be removed from this guidance document once the updated RASML is implemented.
Products intended to produce alkalinisation of the urine should include label warning statements such as:
- Consult a doctor if pain or irritation persists for more than 48 hours or if you notice blood in your urine.
- Do not take this medicine for more than five days unless advised to do so by a doctor.
- Do not give this medicine to children under 12 years of age unless advised to do so by a doctor.
- Check with a doctor or pharmacist before using this medicine if you are taking other medicines or if you have kidney problems, heart problems or high blood pressure.
Vaginal itch, topical preparations
Products containing local anaesthetics will not be approved for the topical treatment or relief of vaginal itch.
For products which are indicated for the treatment of warts, the following statements (or similar) should be included on the labels:
- Do not use if you have diabetes or impaired circulation.
- Use only on common warts. Do not use on moles, birthmarks or unusual skin growths. Do not treat warts over large areas at one time.