Faq

Do I need a prescription for bioXtra?
No, bioXtra products are available without prescription from your local pharmacy.

What does the Medical Device and the MD symbol mean on the bioXtra products?
The Medical Devices Directive (MDD) has recently been replaced by the new Medical Device Regulation (MDR).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:

I am using medication. Is bioXtra safe to use then?
bioXtra products don’t have any influence on medication. Therefore, they can be used together with all sorts of medicines without any problem.

How do I apply bioXtra Oral Gel?
Wash hands thoroughly before use. Apply gel with your finger or a clean swab to gums and tongue or under dentures whenever mouth feels dry, especially before bedtime. Remove or spit out the excess. Repeat when dry mouth symptoms return, without exceeding the recommended daily amount. Close cap after use. Remove or spit out the excess. Repeat as necessary.

What is the best way to apply bioXtra Oral Gel into a patient’s mouth?
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.

Can I use bioXtra Oral Gel under my dentures?
Yes. When you suffer from a lack of saliva the dentures will not stay in place, because there is no adhesion. When you apply bioXtra Oral Gel under your dentures they will feel more comfortable to wear.

How long does bioXtra Oral Gel works?
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.

Can I use bioXtra Gel Mouthspray during the night?
bioXtra Gel Mouthspray is very convenient during daytime but you can also use it at night in case of mild problems. For a longer-lasting effect during nighttime bioXtra Oral Gel is recommended. Avoid drinking/ brushing teeth just after applying the spray.

In the ingredients list it says glucose oxidase. Is this a sugar?
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.

Some bioXtra products contain limonene. Can I use those products?
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.

Are bioXtra products gluten-free?
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)

Are bioXtra products suitable for vegans?
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.

Can I swallow bioXtra Ultra Mild Mouthrinse?
No, bioXtra Ultra Mild Mouthrinse should not be swallowed.

Can I dilute bioXtra Ultra Mild Mouthrinse?
The flavor of  bioXtra Ultra Mild Mouthrinse is very mild. However, if you do prefer to dilute it, use equal amounts of water and mouthrinse and only dilute the quantity that is needed. Do not keep diluted solution.

Do I have to rinse with water after rinsing with bioXtra Ultra Mild Mouthrinse?
No, just spit it out and do not rinse with water. By just spitting out you benefit the most from the enzymes present in the mouthrinse. Avoid drinking/ brushing teeth just after rinsing.

How often can I use bioXtra Ultra Mild Mouthrinse?
bioXtra Ultra Mild Mouthrinse contains 1450 ppm fluoride, so do not exceed 5 times per day.

Can you use bioXtra Toothpaste and Mouthrinse when you don’t suffer from dry mouth?
Yes, bioXtra Toothpaste and Mouthrinse are suitable for people not suffering from dry mouth. They contain enzymes that are also present in natural saliva. bioXtra Ultra Mild Mouthrinse is not suitable for children of 12 years and under. Supervise children as necessary until capable of using without supervision. bioXtra Mild Toothpaste: children of 6 year and younger: use a pea-sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.

Why do I have to close the tubes and bottles after opening?
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.

Why does bioXtra Mild Toothpaste have a low foaming effect?
bioXtra Mild Toothpaste is SLS –free. SLS (sodium lauryl sulphate) is a detergent that – in some cases – can cause painful spots ( aphthous ulcers)  in the mouth. In case of Dry Mouth these problems occur more frequently due to the lack of the natural protective system normally present in saliva. Using bioXtra Mild Toothpaste may help to reduce the onset of aphthous ulcers. However, low foaming does not mean less cleaning, your teeth and gums will be perfectly clean and refreshed after using bioXtra Mild Toothpaste.

What is the carbohydrate content within boXtra Dry Mouth Gel Mouthspray and bioXtra Dry Mouth Oral Gel for diabetic patients?
The calculation about the quantity of carbohydrates contained in the bioXtra mouthspray and oral gel is based on a worst case scenario and according to the quantity likely to be ingested per day.
bioXtra Dry Mouth Gel Mouthspray , when used according to instructions, based on 3.8g of spray/day, a maximum of 350mg of carbohydrates per day would be expected to be ingested.
bioXtra Dry Mouth Oral Gel, when used according to instructions, based on 3g of gel/day, a maximum of 1870mg of carbohydrates per day would be expected to be ingested.
This information is provided in good faith and is accurate to the best of our knowledge according to current scientific documentation available to us. However, in case of any doubt of suitability for use for specific disorders, please seek advice from a medical practitioner.

I am on a low-salt diet. How much salt (sodium) is present in the bioXtra products?
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.

What is the quantity of potassium within the oral gel and the gel mouthspray and would this impact the risk of hyperkalaemia?
The potassium concentration in bioXtra products:

1. BioXtra Dry Mouth Oral Gel, on basis of the daily recommended intake of 3gr.: 1,3mg/day
2. BioXtra Dry Mouth Gel Mouth Spray , on basis of the daily recommended intake of 3,8ml: 5mg/day

The recommended daily amount (RDA) of potassium for adult men is 3400 mg and for women it is 2600 mg. Our advice would be to contact your doctor once you’ve provided the information on the amount you’re likely to ingest per day.

Is bioXtra Gel and Mouthspray safe to swallow?
Yes, biocompatilility studies demonstrate that at the recommended daily dosage, although they are designed to achieve their purpose in the oral cavity, both products are perfectly safe to swallow. Please always take into consideration possible allergies and consult the packaging and ingredient labelling for information. It is also important to avoid an accumulation of gel in the throat for bed-ridden patients, or for those who are unable to swallow easily. In case of doubt, consult a physician. The Mouthrinse and Toothpaste are not intended to be swallowed.

Are there other causes of dry mouth besides the known medical causes?
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)

Can I be reimbursed when I purchase bioXtra products in my local pharmacy?
When a doctor or dentist prescribes the product a reimbursement may be applicable depending on the country where you live. Please ask your pharmacist or contact your private health insurance if applicable.
bioXtra products are also prescription-free and can be purchased at your pharmacy.

Can I use bioXtra if I have damaged mucosa in my mouth?
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.

Are the bioXtra products dematologically tested?
All bioXtra products have been dermatologically tested and are non-irritant.

Are the bioXtra products clinically supported?
The efficacy of all bioXtra products has been clinically supported for over 20 years and a wealth of clinical articles exists justifying their performance and safety.