Dentaguttal^® (Drops) Instructions for Use

Marketing Authorization Holder

Moscow Pharmaceutical Factory CJS (Russia)

Contact Information

Moscow Pharmaceutical Factory CJS (Russia)

ATC Code

A01AD11 (Other drugs)

Active Substances

Camphor (Ph.Eur. European Pharmacopoeia)

Peppermint oil (BP British Pharmacopoeia)

Valerian (BP British Pharmacopoeia)

Dosage Form

Dentaguttal®

Dental drops 3.1 g+6.4 g+90.5 g/100 ml: 10 ml dropper bottle, 10 ml bottle with dropper cap

Dosage Form, Packaging, and Composition

Dental drops in the form of a clear reddish-brown liquid with an aromatic odor.

10 ml – dark glass dropper bottles (1) – cardboard packs.
10 ml – dark glass bottles with dropper cap (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with analgesic and sedative action for topical application in dentistry

Pharmacotherapeutic Group

Local irritant

Pharmacological Action

A combined drug; it has a locally irritating (counterirritant), moderately analgesic, antiseptic, and sedative effect.

Indications

• Use for the symptomatic relief of toothache of various origins as a temporary measure.
• Apply topically to the affected tooth to provide a local analgesic and sedative effect.
• Intended for short-term use until professional dental care can be obtained; it does not treat the underlying cause of the pain.

ICD codes

Dosage Regimen

Apply topically only; do not swallow. Use a piece of cotton wool as an applicator.

Apply 2-3 single doses onto the cotton wool and place it directly onto or against the affected tooth and the surrounding gum area.

This application can be repeated as needed for pain relief, but it is for temporary use only until a dentist can be consulted.

Adverse Reactions

Local reactions: at the application site, allergic reactions such as skin rash, itching, or redness may occur.

Direct contact with the oral mucosa can cause a transient but noticeable burning sensation.

Discontinue use immediately and rinse the mouth thoroughly with water if severe irritation or any signs of a hypersensitivity reaction develop.

Drug Interactions

Formal drug interaction studies have not been conducted due to the topical route of administration and local action.

Consider the potential for additive sedative effects with other central nervous system depressants, such as alcohol, barbiturates, or benzodiazepines, although systemic absorption is expected to be low.

Inform your physician about all other medications you are taking before using this product.

Contraindications

• Hypersensitivity to camphor, peppermint oil, valerian tincture, or any other component of the formulation.
• Pregnancy at any trimester due to the lack of safety data and the known risks associated with ingredients like camphor.
• The period of breastfeeding (lactation) to prevent the transfer of active components to the infant.
• Use in children under 12 years of age because of a higher risk of accidental ingestion and increased sensitivity to the effects of camphor.

Overdose

In case of accidental ingestion, seek immediate medical attention or contact a Poison Control Center.

Symptoms of camphor overdose may include nausea, vomiting, abdominal pain, dizziness, agitation, confusion, hallucinations, and seizures.

There is no specific antidote; treatment is supportive and symptomatic. Do not induce vomiting.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation (breastfeeding).

Pediatric Use

Contraindicated in children under 12 years of age.

With caution: children over 12 years of age.

Special Precautions

Effect on the ability to drive vehicles and operate machinery

During treatment, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving machinery, work of a dispatcher and operator).

Storage Conditions

Store at 2°C (36°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.