Dental drops

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT DENTAL DROPS

Composition:

Active substances: 1 ml of the preparation contains peppermint oil (calculated as 50% menthol) 31 mg, racemic camphor 64 mg, valerian root tincture (Valerianae radix) (1 : 5) (extractant – 70% ethanol) up to 1 ml;

1 ml of the preparation contains 46 drops.

Pharmaceutical form. Drops.

Main physico-chemical properties: clear liquid, ranging in color from yellowish-brown to reddish-brown, with an aromatic odor.

Pharmacotherapeutic group.

Agents for local use in dentistry.

ATC code A01A D11.

Pharmacological properties.

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

Clinical characteristics.

Indications.

Symptomatic treatment of dental pain of various etiologies.

Contraindications.

Individual hypersensitivity to the components of the drug, epilepsy, predisposition to seizures, bronchial asthma; avoid contact with damaged mucous membranes.

Special precautions.

If undesirable allergic reactions occur, discontinue use of the drug and wash off any residue from the application sites.

Interaction with other medicinal products and other forms of interaction.

There is no information available on possible interactions.

Special precautions.

Use during pregnancy or breastfeeding.

Since the formulation contains ethyl alcohol, the drops are not recommended for use in women during pregnancy and breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

Since the formulation contains ethanol, caution is advised when driving or operating machinery due to possible adverse reactions (dizziness, drowsiness).

Method of Administration and Dosage

To relieve toothache, apply a cotton swab moistened with 2–3 drops of the medication to the affected tooth.

Do not swallow the drops!

Children

The drops are not recommended for children under 12 years of age.

Overdose

Hypersensitivity to the drug and intensification of adverse effects may occur.

In case of accidental ingestion, severe gastrointestinal symptoms may develop, including abdominal pain, nausea, vomiting, diarrhea, rectal ulcers, symptoms of central nervous system depression, dizziness, ataxia, seizures, loss of consciousness, hot flashes, drowsiness, respiratory difficulty, headache, excitement, cardiac dysfunction, and decreased arterial blood pressure.

Treatment is symptomatic.

Adverse Reactions.

Immune system reactions

Allergic reactions may sometimes occur, including skin rash, urticaria, itching, erythema, anaphylactic shock.

Nervous system reactions

Headache, dizziness, drowsiness, ataxia, tremor, seizures, excitation.

Cardiovascular system reactions

Bradycardia.

Respiratory system reactions

Bronchospasm.

Local reactions at the site of administration

Irritation of mucous membranes, burning sensation.

Shelf life. 2 years.

Storage conditions.

Store in original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 10 ml in bottles.

Supply category.

Over-the-counter.

Manufacturer.

JSC "FITOPHARM".

Manufacturer's address and place of business.

84500, Bakhmut, Sibirtseva St., 2, Donetsk region, Ukraine.

Marketing authorization holder.

JSC "FITOPHARM".

Address of the marketing authorization holder.

7, Verkhovnoyi Rady Ave., premises 18, 3rd floor, 02100, Kyiv, Ukraine.