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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.
Current medical opinion indicates that the use of ear drops should be limited to:
- the prevention or treatment of medically diagnosed otitis externa; or
- the treatment of 'swimmer's ear'; or
- wax softening (wax softeners should be bland and non-irritating).
Any other proposed indications should be justified.
Product labels should advise that, in cases of ear perforation (or where there is a likelihood of ear perforation) or where grommets (ventilation tubes) are present, medical advice should be sought before ear drops are used.
Applications for registration of an ear drop containing a local anaesthetic should be accompanied by evidence of safety and efficacy.
'Easy breathing', use of term
Terms that imply 'easy breathing' may mislead people with asthma. Such terms will not be accepted in isolation, but must be qualified by reference to the actual condition being treated (e.g. "by drying the secretions of the nose, this product makes breathing easier").
Electrolyte replacement products
Electrolyte replacement products should be labelled and formulated to conform to the recommendations of an accepted authority (e.g. the British Pharmacopoeia, World Health Organisation). Other formulations will be considered but must be justified.
See also 'Diarrhoea treatments'
Eucalyptus oil should not be used in oral preparations (other than as a flavouring agent) because of its toxicity and lack of therapeutic benefit.
In the absence of clinical evidence to support the inclusion of eucalyptus oil in steam inhalant solutions, registration of such products will not be approved.
Guaiphenesin is the only substance recognised as an expectorant. Sponsors wishing to use the term 'expectorant' for any other ingredient should provide clinical data to support the claim.
The Therapeutic Goods Order No. 69 - General requirements for labels for medicines requires a statement on the label that eye preparations must be discarded four weeks after the date of initial opening. Consumers will be assisted if space is provided on the label for the user to write the date when the container is first opened.
Applications to register a new eye preparation should address the possibility of interactions between the eye preparation and contact lens materials, and a suitable statement should be included on the product label where appropriate.
Vasoconstrictor eye drops
Warnings to the following effect should be included on the primary pack label or package insert for vasoconstrictor eye drops:
- *Prolonged use may be harmful.
- *Consult a doctor or pharmacist if using other eye products.
- *Do not use if you have glaucoma or other serious eye conditions.
- *If symptoms persist, consult a doctor.
The indications for vasoconstrictor eye drops should not include references to close work, tiredness, driving or similar non-specific claims.
The product name and label text should not encourage inappropriate use for trivial or cosmetic purposes. References to 'soothing' or 'whitening' in the presentation of the product will not be accepted.
Fluoride supplements (drops, tablets) should not be taken during pregnancy.
The labelling of fluoride supplement products should include advice consistent with the following:
- *This product should only be used on the advice of a dentist.
- *Do not use if pregnant.
For products which are indicated for the treatment of haemorrhoid, the following statements (or similar) should be included on the labels:
- If symptoms persist, seek medical advice.
Head lice treatments
Evidence suggests that the efficacy of head lice treatment products is formulation dependent. Sponsors of new products should provide data to support the efficacy of their specific formulation when used according to the directions for use on the product's label.
The efficacy and safety of head lice products should generally be supported by relevant clinical trials, rather than in vitro data only. In vitro data may be acceptable, at the discretion of the TGA, where the formulation of a product is similar to a product registered in Australia that has been fully evaluated, and the sponsor provides a justification in support of the registration of the proposed formulation.
Efficacy data should ideally consist of clinical trials conducted in Australia, to address location-specific resistance issues. Claims for registered products must be limited to control/treatment of head lice and their eggs (except see below regarding prophylactic use). Since no pediculocides have been shown to be 100% insecticidal and ovicidal under all conditions of use, claims must not state or imply that one treatment can kill all lice and their eggs.
must not claim prophylactic use (preventative or repellent action) as an indication unless they can provide satisfactory evidence that such use of the product will not promote the development of resistance. Safety and efficacy of prophylactic use must also be supported by clinical trial data.
The use of lindane and benzyl benzoate in products registered for the treatment of head lice infestation is discouraged.
Labels and/or package inserts should include information consistent with the following (or information consistent with the clinical trial protocol as appropriate) immediately after the dosage instructions:
- Use enough to thoroughly cover the scalp, including the back of the neck and behind the ears.
- If the product gets into the eyes, rinse out immediately with water.
- Remove all the eggs (nits) you can find after treatment (this is easier with a fine tooth comb and hair conditioner on wet or dry hair).
- Repeat the treatment after 7-10 days to kill lice that have hatched from any remaining eggs that were not killed by the first treatment.
- If you find live lice or more eggs appear after the second treatment, seek advice from a health care professional.
- Only use the product when you can see live lice or their eggs. Don't use regularly or to prevent head lice.
- Check other people in the household and treat if necessary. Lice can quickly spread back to people who have already been treated.
- Don't use on babies under 6 months, except on medical advice.
Because education is an important component of treatment, sponsors are encouraged to make available relevant public health information on the treatment of head lice infestation in a package insert, a web site referenced on the label or by other means (e.g. a telephone information service).
Further information on head lice products is included in the document, A review of the regulation of head lice preparations in Australia, which is available on the TGA website.
See also 'Lindane'
Use of hydroquinone to treat the hyperpigmentation caused by pregnancy will not be approved, as this condition is self-limiting.
In addition to the label warnings required by the RASML, labels of products containing hydroquinone should include the following warning:
- *Long term and repeated use should be avoided because darkening of the skin could occur.
Other substances in the formulation may enhance absorption of hydroquinone. Sponsors should take this into account in formulating products and address this issue as part of the registration application.
Hypoallergenicity of topical preparations
Where a product contains a claim of hypoallergenicity, evidence must be provided that the product has been tested in hypersensitive subjects or found to pass a suitable test such as the Kligman Maximisation Test. The guinea pig (Kligman) maximisation test, Buehler test and mouse local lymph node assay are internationally accepted, routine assays for testing sensitisation potentials of chemicals/drugs. However, of these tests, only the Guinea pig maximisation test uses a test method of "maximising"/"magnifying" the sensitising effects of the test material since this test involves intra-dermal injection and adjuvant to "magnifying" the sensitising activity of the test material.
Repeat Insult Patch Testing (RIPT) is not a suitable substitute, as it is not conducted in a system that has magnified responsiveness as would be encountered in a sensitive individual.