Colgate® Duraphat® Fluoride Varnish – The ONLY varnish to use for caries control†

Prevention is the cornerstone of modern dentistry, irrespective of setting. The most progressive preventive care often includes a comprehensive approach including patient-led actions (such as behaviour change) alongside evidence-based professional-led actions (such as patient education and professional interventions).¹

Despite improvements, dental caries remains a concern.^2-5 Latest data shows 33% of children present with obvious caries with an average of 3.5 teeth affected.^3-5 Caries is not limited to children, with over 1 in 4 adults presenting to general dental practice with active caries affecting an average of 2.1 teeth.²

Not all fluoride varnishes are the same

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.⁶
• A medical device’s principal mode of action does not include treating or preventing disease.⁷

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.⁷ 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.⁶

Why does this matter?

Delivering better oral health guidance recommend twice yearly application of 22,600ppm fluoride varnish for all children aged 3 years and above for caries prevention. This increases to 3-monthly applications for those at increased caries risk. For adults at increased caries risk, it may be a 3 or 6-monthly application, dependant on their caries pathway.^1,8

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 6 months following application.^9,10 For this reason, the evidence-base also states to use a fluoride varnish licensed for caries control.¹ 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.^11,12  This point is also important for appropriately trained extended duties dental nurses (EDDNs)^11,12 and for dental hygienists and dental therapists working to exemptions.¹³

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.¹⁴ 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. Seeing this type of information allows dental professional to understand if the product is classified as a medicine. The other indicator is the product licence number on the outer carton.

For clarity, it is also worth mentioning the alcohol in Colgate® Duraphat® Fluoride Varnish. This promotes the flow of the product during application and because it is being used as a medicament and is not an intoxicant, it has been agreed (on the authority of the West Midlands Shari’ah Council) that it is suitable for use by Muslims,¹ provided that the product is used in small amounts, well below those which would intoxicate, and is not being used for reasons of vanity.

Applying Colgate® Duraphat® Fluoride Varnish

Delivering better oral health guidance¹ states that fluoride varnish is one of the best options for increasing the availability of topical fluoride regardless of the levels of fluoride in any water supply. The guidance also states it is quick, easy and does not provide any aesthetic challenges.

Prior to applying the fluoride varnish advise the patient, parent or carer on the purpose, benefits, process, possible side effects and alternatives to fluoride varnish.¹⁵ 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.

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 4 hours after application if desired. This tint acts as a useful guide which may be helpful when applying to a fidgety child. A tint is not usually seen as a problem when applying for caries control, as it is usually applied to vulnerable surfaces including pits and fissures and approximal surfaces, unlike when applying to cervical margins as a desensitiser.

Let your patients know Colgate® Duraphat® Fluoride Varnish has a pleasant raspberry taste and fruity smell.¹⁶ 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.¹⁷  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.¹⁷  These alternative approaches would offer the child an element of control. 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 6 month period.⁹

Dispense Colgate® Duraphat® Fluoride Varnish, onto a Duraphat® Varnish dispensing pad using the dosage circle relating to the patient’s dentition. This visual guide helps support safety in terms of maximum dosage applied. This is  as an alternative to dispensing small amounts at a time on the back of a glove or in a Dappen dish, with the potential of losing track of the total amount dispensed.

Dry the teeth using a cotton wool roll. Colgate® Duraphat® Fluoride Varnish sets in the presence of saliva so there is no need to totally dry the teeth. This means Colgate® Duraphat® Fluoride Varnish can be used in many settings including the community, even with the child sitting on a bean bag. Although Colgate® Duraphat® Fluoride Varnish sets in the  presence of saliva, it is useful to start the application on the lower arch to help manage any excess saliva during the application process.

The majority of fluoride varnish applications are for caries control in children. However, it is increasingly important to consider their use with 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 10 year NHS plan.¹⁸

Post application instructions

Advise your patient that they should not eat or drink for 30 minutes following the application and only to eat soft foods for the next four hours. Also advise your patient their toothbrushing should be suspended for the remainder of the day but should resume the following morning. They should have no high fluoride preparations including fluoride supplements on the day of application.

Protect your patients, your team and your dental practitioners’ responsibilities with Colgate® Duraphat® Fluoride Varnish.^1,11-13,18

Click here for more information on Colgate® Duraphat® Fluoride Varnish.

†Colgate® Duraphat® fluoride varnish for patients 3 years of age and over.

References:

1. 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.
2. Oral Health Survey of Adults attending dental practices, 2018. Public Health England, published 2020.
3. National Dental Epidemiology Programme for England, Oral health survey of 3-year-old children 2020: a report on the prevalence and severity of dental decay, Public Health England.
4. National Dental Epidemiology Programme for England, Oral health survey of 5-year-olds 2022, Office for Health Improvement & Disparities.
5. Child Dental Health Survey 2013, England, Wales and Northern Ireland National statistics, published 2015.
6. https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medicine
7. https://www.gov.uk/guidance/borderline-products-how-to-tell-if-your-product-is-a-medical-device
8. Dental contract quality and payment reforms, DHSC Consultation Webinar, Tuesday 15^th July 2025.
9. Seppa L. Fluoride content of enamel during treatment and 2 years after discontinuation of treatment with fluoride varnishes. Caries Res 18, 278-281, 1984.
10. Marinho VCC, Worthington HV, Walsh T, Clarkson JE. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database of Systematic Reviews 2013.
11. The use of fluoride varnish by dental nurses to control caries. NHS. Primary Care Commissioning, 2009.
12. 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
13. 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/
14. https://products.mhra.gov.uk/
15. Professionally-delivered interventions in caries prevention, SDCEP. 2025. https://www.childcaries.sdcep.org.uk/guidance/caries-prevention/professionally-delivered-interventions/
16. Fluoride varnishing, Childsmile, NHS Scotland. 2025. https://www.childsmile.nhs.scot/parents-carers/fluoride-varnishing/
17. Using flavour in your favour: does giving children an element of control help them engage more positively with the dental experience?. Cunningham, B., Linden, J. Evid Based Dent 26, 97–98 (2025). https://doi.org/10.1038/s41432-025-01162-3
18. ‘FIT FOR THE FUTURE’ 10 Year Health Plan for England. NHS England. 2025.