Colgate explains the benefits of its Duraphat Fluoride Varnish for caries control in dental treatment.
Dental teams are presented with a wide range of professional products to support caries prevention including fluoride varnish. It is vital to understand that not all fluoride varnishes are the same. Although they may have similar compositions, they are intended for a different use. This difference can be clearly identified by their regulatory status as defined by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA states:
- A medicine is any substance or combination of substances presented as having properties for treating or preventing disease in human beings (MHRA, 2025)
- A medical device’s principal mode of action does not include treating or preventing disease (MHRA, 2023).
Colgate Duraphat Fluoride Varnish is the only fluoride varnish with the legal status of a medicine, indicated for caries control. All other fluoride varnishes currently on the UK market are medical devices, providing treatment of hypersensitive teeth only.
Although some may also suggest an implied caries benefit, this is not their intended purpose or mode of action. As a medical device their primary mechanism is to act by physical or mechanical means (MHRA, 2023). Medicines, on the other hand, act through pharmacological (as is the case with Colgate Duraphat Fluoride Varnish, licensed to deliver caries control), metabolic, or immunological effects (MHRA, 2025).
Why does this matter?
Delivering better oral health guidance recommend twice yearly application of 22,600ppm fluoride varnish for all children aged three years and above for caries prevention. This increases to three-monthly applications for those at increased caries risk. For adults at increased caries risk, it may be a three- or six-monthly application, dependant on their caries pathway (OHID, 2020; DHSC, 2025).
To be clinically effective, a fluoride varnish delivering caries control should release free fluoride ions to both promote remineralisation and inhibit demineralisation during any drop in pH for six months following application (Seppa, 1984; Marinho et al, 2013). For this reason, the evidence-base also states to use a fluoride varnish licensed for caries control (MHRA, 2025).
Colgate Duraphat Fluoride Varnish is the only licensed product available. Using a fluoride varnish licensed for caries control also meets dental practitioner’s responsibilities as a prescriber (NHS, 2009; NHS England, 2016). This point is also important for appropriately trained extended duties dental nurses (EDDNs) and for dental hygienists and dental therapists working to exemptions (NHS, 2009; NHS England, 2016; NHS England, 2025).
Transparent information
Unlike other fluoride varnishes which are all medical devices, the Colgate Duraphat Fluoride Varnish product licence information is publicly accessible via the MHRA website (MHRA, 2025). This includes the Summary of Product Characteristics (SPC) which lists everything you need to know to make a considered choice prior to application. It includes the product indication which is:
‘For the prevention of caries in children and adults as part of a comprehensive control programme
- For the prevention of recurring (or marginal) caries
- Prevention of progression of caries
- Prevention of decalcification around orthodontic appliances
- Prevention of pit and fissure (occlusal) caries.’
This prescribing information can also be found in an abridged format on all marketing materials for Colgate Duraphat Fluoride Varnish.
Application
Prior to applying the Colgate Duraphat fluoride varnish, advise the patient, parent or carer on the purpose, benefits, process, possible side effects and alternatives to fluoride varnish (SDCEP, 2025). Ensure the patient has eaten prior to the application and let them know that the fluoride varnish is applied using a small brush and that it is quick, simple and painless. Let your patients know Colgate Duraphat Fluoride Varnish has a pleasant raspberry taste and fruity smell (NHS Scotland, 2025).
It is also useful to understand that the opaque yellowish tint found in Colgate Duraphat Fluoride Varnish is only temporary. It will wear off or can be brushed off four hours after application if desired. This tint acts as a useful guide which may be helpful when applying to a fidgety child.
Does fluoride varnish flavour affect treatment acceptance?
Other fluoride varnishes (not licensed for caries control) can offer a range of flavours intended to engage children. This may cause confusion by implying the product could be used for caries control in children. A paper on the use of flavoured fluoride varnishes was recently reviewed, suggesting that flavour is not an effective way to engage a child (Cunningham and Linden, 2025).
The review suggested a better way of engaging a child would be to offer them a choice of safety glasses or ask them which side of the arch they would like to start on to offer the child an element of control (Cunningham and Linden, 2025). More importantly, the child would be receiving Colgate Duraphat Fluoride Varnish, clinically proven to release fluoride ions to both promote remineralisation and inhibit demineralisation during any drop in pH within a six-month period (Seppa, 1984).
It is increasingly important to consider fluoride varnish application for adults at higher caries risk. This includes the planned caries pathways for higher risk adults put forward as part of the proposed dental reform, aligning with the NHS 10-Year Health Plan (NHS England. 2025).
Protect your patients, your team and your dental practitioners’ responsibilities with Colgate Duraphat Fluoride Varnish.
Click here for more information on Colgate Duraphat Fluoride Varnish.
†Colgate Duraphat Fluoride Varnish is for patients three years of age and over.
References
- https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine
- https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device
- Delivering better oral health – an evidence-based toolkit for prevention, Office for Health Improvement and Disparities’ 2021.Oral Health Survey of Adults attending dental practices, 2018. Public Health England, published 2020.
- Dental contract quality and payment reforms, DHSC Consultation Webinar, Tuesday 15 July 2025
- Seppa L, Fluoride content of enamel during treatment and 2 years after discontinuation of treatment with fluoride varnishes. Caries Res 18, 278-281, 1984.
- Marinho VCC, Worthington HV, Walsh T, Clarkson JE. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews 2013.
- The use of fluoride varnish by dental nurses to control caries. NHS. Primary Care Commissioning, 2009.
- Avoidance of Doubt – Application of Fluoride Varnish by Dental Nurses. Chief Dental Officer, NHS England. 2016. https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2016/09/avoidance-doubt-v4-1.pdf
- Supply and administration of medicines by dental hygienists and dental therapists, NHS England. 2025. https://www.england.nhs.uk/long-read/supply-and-administration-of-medicines-by-dental-hygienists-and-dental-therapists/
- https://products.mhra.gov.uk/
- Professionally-delivered interventions in caries prevention, SDCEP. 2025. https://www.childcaries.sdcep.org.uk/guidance/caries-prevention/professionally-delivered-interventions/
- Fluoride varnishing, Childsmile, NHS Scotland. 2025. https://www.childsmile.nhs.scot/parents-carers/fluoride-varnishing/
- Cunningham, B, Linden, J. Using flavour in your favour: does giving children an element of control help them engage more positively with the dental experience? Evid Based Dent 26, 97–98 (2025). https://doi.org/10.1038/s41432-025-01162-3
- 10-Year Health Plan for England. NHS England. 2025.
This article is sponsored by Colgate.
