Denta drops

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DENTA DROPS

Composition:

Active substances: chloral hydrate, racemic camphor;

1 ml of the preparation contains 333 mg of chloral hydrate and 333 mg of racemic camphor;

Excipient: ethanol 96%.

Pharmaceutical form. Dental solution.

Main physicochemical characteristics: colorless transparent liquid with a camphor odor.

Pharmacotherapeutic group.

Agents for local use in dentistry.

ATC code A01A D11.

Pharmacological properties.

Pharmacodynamics. The medicinal product exerts a moderate analgesic and antiseptic effect, determined by the pharmacological properties of the substances contained in its composition.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Dental pain due to caries, including caries complicated by pulpitis.

Contraindications.

Increased individual sensitivity to the substances contained in the drug, predisposition to seizures, bronchial asthma.

Avoid contact of the solution with damaged mucous membranes.

Interaction with other medicinal products and other forms of interaction.

Interaction is currently unknown.

Special precautions.

If any adverse reaction occurs, discontinue use of the medication and wash off any residue from the application sites.

Use during pregnancy or breastfeeding.

Since the medicinal product contains ethanol, it should not be administered to pregnant women or women who are breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The medication affects psychomotor reaction speed; therefore, driving vehicles or operating machinery should be avoided during treatment.

Method of Administration and Dosage.

For use in adults.

To relieve toothache, place a cotton swab moistened with 2–3 drops of the preparation into the carious cavity of the tooth for 5–10 minutes.

Children.

The preparation should not be used for treatment of children.

Overdose.

In case of accidental ingestion, symptoms may include abdominal pain, nausea, vomiting, diarrhea, signs of central nervous system depression, dizziness, ataxia, seizures, flushing, drowsiness, and respiratory difficulty. Treatment is symptomatic.

Side effects.

Nervous system disorders: dizziness, drowsiness, headache, excitement, seizures.

Respiratory system and thoracic disorders: bronchospasm.

Allergic reactions, including skin rash, urticaria, itching, erythema.

Shelf life. 4 years.

Storage conditions.

Store in a light-protected place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml in bottles, in a carton or without carton, or 20 ml in dropper bottles, in a carton or without carton.

Supply category. Over-the-counter.

Manufacturer/Marketing authorization holder.

LLC "Ternofarm".

Address of manufacturer and location of its business activity / address of the marketing authorization holder.

LLC "Ternofarm".

4 Fabrychna Street, Ternopil, 46010, Ukraine.