Dentispray 50 mg/ml dental solution
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
dentispray 50 mg/ml dental solution
Benzocaine
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve within 2 days of treatment.
Contents of this leaflet:
- What Dentispray is and what it is used for
- What you need to know before using Dentispray
- How to use Dentispray
- Possible adverse effects
- How to store Dentispray
- Contents of the pack and other information
1. What Dentispray is and what it is used for
It is a topical anesthetic that works by suppressing pain when applied externally to the affected area in the mouth.
This medicine is used for the symptomatic relief of mouth, tooth, and gum pain in adults and children over 2 years of age, until proper treatment by a dentist can be obtained.
You should consult a doctor if symptoms worsen or do not improve after 2 days of treatment.
2. What you need to know before using Dentispray
Do not use Dentispray
If you are allergic to benzocaine, to other local anaesthetics derived from para-aminobenzoic acid, or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Dentispray.
- If you are intolerant to other local anaesthetics such as para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (a component of hair dyes).
- If you have a serious or extensive lesion in the mouth.
- Doses higher than those recommended in section 3 (How to use Dentispray) must not be taken.
- Elderly or debilitated patients should consult their doctor before using this medicine, as they are more sensitive to potential adverse reactions.
- Avoid spraying near the eyes.
- Do not inhale or swallow.
- Do not eat or drink while numbness in the mouth persists, due to the risk of biting your tongue or oral mucosa and choking.
- Keep away from fire or flames. Do not smoke during application.
Use of Dentispray with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
This medicine may interact with:
- Sulfonamides (medicines used to treat infections): they should not be used simultaneously with benzocaine, as it may reduce the antibacterial effect of sulfonamides.
- Medicines containing hyaluronidase: they should not be used simultaneously with benzocaine, as it may increase the adverse effects of benzocaine.
- Other local anaesthetics.
- In individuals sensitive to benzocaine, hair dyes of the paraphenylenediamine type may cause severe contact dermatitis.
Use of Dentispray with food and beverages
Do not use this medicine before meals or before drinking (see section Warnings and precautions).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Benzocaine should not be used during pregnancy.
It is unknown whether benzocaine is excreted in breast milk; therefore, women who are breastfeeding should not use this medicine.
Driving and using machines
The effect of this medicine on the ability to drive and operate machinery is none or negligible.
3. How to use Dentispray
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
- Adults and adolescents
1 application. Apply to the affected area 3 or 4 times a day. Do not apply more than 4 times a day.
Each spray delivers approximately 3 mg of benzocaine.
- Use in children
Children aged 6–12 years: only under adult supervision, apply as described above.
Children aged 2–6 years: under medical supervision.
Children under 2 years: under strict medical supervision.
Method of administration
This medicine is for oral use.
Do not inhale or swallow.
Remove the cap from the bottle and place the spray nozzle, with the integrated applicator tube, onto the outlet tube of the metering pump. Press the nozzle several times until the pump is filled. The medicine can then be applied either directly by pressing the nozzle and directing the solution through the tube to the painful area, or by soaking a piece of cotton wool with several sprays and holding it against the affected area for a short period of time. After treatment, it is recommended to rinse the applicator tube with water, dry it, and store it.
If symptoms worsen or persist after 2 days of treatment, consult your dentist.
If you use more Dentispray than you should
Signs of overdose may include: bluish discoloration of the skin, slurred speech, numbness, unsteady gait, blurred or double vision, dizziness, excitement or convulsions, ringing in the ears, and increased sweating. Blood pressure may also decrease.
In case of overdose or accidental ingestion, seek immediate medical advice or go to a medical center, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported during the period of use of benzocaine, although their frequency cannot be precisely determined:
Urticaria, edema, anaphylactoid reaction (contact dermatitis). Cross-reactions with other ester-type local anesthetics. Photosensitivity, bad taste in the mouth, mucosal dehydration, and difficulty swallowing.
Sensation of oral burning.
Methemoglobinemia, whose symptoms are: headache, dizziness, shallow breathing, nausea, fatigue, or tachycardia.
Prolonged contact of benzocaine with oral mucous membranes may cause dehydration of the epithelium and hardening of the oral mucosa.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dentispray
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date which is stated on the carton and container after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the package and other information
Composition of Dentispray
- The active substance is benzocaine. Each milliliter of dental solution contains 50 mg of benzocaine.
- The other components (excipients) are: polyethylene glycol 400, purified water, sodium saccharin, thymol, menthol, peppermint oil, peppermint essence, disodium phosphate dodecahydrate, and 96% ethanol.
Appearance of the product and contents of the container
Dentispray is supplied in 5 ml aluminum bottles containing a dental solution, equipped with a metered pump and an applicator nozzle integrated into the actuator. The solution is a clear, colorless liquid with a characteristic odor.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Viñas, S.A.
Provenza, 386
08025- Barcelona
Spain
Manufacturer
Laboratorios Viñas, S.A.
Torrente Vidalet, 29
08012 Barcelona
Spain
Laboratorios Viñas, S.A.
Polígono Industrial Can Rosés, Avenida Can Rosés, s/n,
08191 Rubí
Spain
Date of the most recent revision of this leaflet: July 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/