No, bioXtra products are available without prescription from your local pharmacy or online through this store.

The Medical Devices Directive (MDD) has recently been replaced by the new Medical Device Regulation (MDR). The bioXtra products with the exception of the toothpaste are classified as Class IIa under the new MDR regulation. The bioXtra range is the first European range of dry mouth products to have successfully passed this transition. A Quality Management System has been set up to manage production in this product category and the technical file supports the safety, efficacy and claims.

With the new MDR regulation, there are no more grey areas or doubts:

• either oral care products are classified as category IIa (with an annual surveillance audit by a notified body).

• or the products are classified as cosmetics, in which case they may not be associated with medical claims in any shape or form.
  

You can recognize an MDR classified medical device by this symbol: MD

bioXtra products don’t have any influence on medication. Therefore, they can be used together with all sorts of medicines without any problem.

When used in a clinical environment, follow good hygiene practices.
Preferably place the patient in an upright or semi-upright position before applying.

Remove or have patient spit out any excess of previously applied gel before each new application. Extra care should be taken when applying to patients who have difficulty in swallowing.

bioXtra Oral Gel can also be used in case of PEG feeding or oxygen therapy.

In fact the dryer the mouth the longer the Oral gel stays in place. For long-lasting lubrication and comfort, especially at night, apply bioXtra Gel before going to sleep. Avoid drinking/ brushing teeth just after applying the gel.

No, glucose oxidase is not a sugar but an enzyme that is activated by the glucose from our food and drinks. During this activation the glucose level in your mouth is in fact reduced because it will be consumed by the enzyme. Glucose oxidase is safe for natural teeth.

The presence of limonene does not have much relevance in the oral cavity regarding skin allergy. If you eat an orange or drink orange juice the concentration of limonene in the mouth and on the lips is very much higher. However, if you do have a known allergy to limonene, it would be advisable to avoid using the bioXtra products that contain it, i.e. the ultra-mild mouthrinse and the mild toothpaste. You can safely use the gel mouthspray and the oral gel. If you are in any doubt, please consult a specialist.

bioXtra Oral gel and Gel Mouthspray contain traces of gluten, but below the threshold of 20ppm, meaning that the products are considered gluten-free according to the Codex Alimentarius. (https://nl.wikipedia.org/wiki/Codex_Alimentarius).

bioXtra products contain milk derivatives (Colostrum, Lactoferrin, Lactoperoxidase) and an egg-white derivative (Lysozyme). If you choose to avoid animal-derived materials bioXtra products are not suitable for you.

The enzyme system in bioXtra products is activated by oxygen. If you leave the product open, oxygen will penetrate into the tube or bottle decreasing the efficacy of the product.

For the following bioXtra products, of which a small amount can possibly be swallowed, the sodium content, calculated according to the daily dosage is:

• Spray:  7,2mg
• Gel : 6,3mg
• For the Mouthrinse, this product is intended to be spat out so the risk of ingesting sodium is negligible.

Besides the other well-known medical conditions associated with dry mouth, life-style habits or natural causes can have an influence on your saliva production and cause Dry Mouth, such as:

• Ageing
• The use of alcohol
• Smoking, vaping or the use of chewing tobacco (snus)

bioXtra products have been evaluated as safe if they come into contact with damaged or compromised mucosa. If you experience any stinging or unpleasant sensation in case of contact with damaged mucosa, rinse your mouth thoroughly and refrain from using the product until the mucosa has fully healed.