Dentaplus (Drops) Instructions for Use

Marketing Authorization Holder

Pharmstandard-Fitopharm-NN LLC (Russia)

ATC Code

A01AD11 (Other drugs)

Active Substances

Peppermint oil (BP British Pharmacopoeia)

Valerian (BP British Pharmacopoeia)

Camphor (Ph.Eur. European Pharmacopoeia)

Dosage Form

Dentaplus

Dental drops: 10 ml dropper bottle.

Dosage Form, Packaging, and Composition

10 ml – dark glass dropper bottle (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 medicinal product; it has a locally irritating (counterirritant), moderately analgesic, antiseptic, and sedative effect.

Indications

• For the temporary relief of toothache of mild to moderate intensity.
• Use as a symptomatic treatment for dental pain prior to professional dental consultation and intervention.

Apply only for topical use within the oral cavity on the affected tooth or surrounding gum area.

ICD codes

Dosage Regimen

Apply topically only. Place 2-3 drops onto a small piece of sterile cotton wool.

Apply the medicated cotton wool directly to the surface of the painful tooth or into the carious cavity. Avoid contact with healthy oral mucosa and gingiva to prevent local irritation.

Use as needed for pain relief, but seek definitive dental care. This is not a substitute for professional treatment.

Adverse Reactions

Local reactions: Allergic reactions, including skin rash, itching, and redness at the application site.

Direct contact with the oral mucosa may cause a transient burning sensation or irritation. Discontinue use immediately if severe irritation or signs of a hypersensitivity reaction occur.

Contraindications

• Hypersensitivity to camphor, peppermint oil, valerian tincture, or any other component of the formulation.
• Patients with a history of severe allergic reactions to plants of the Lamiaceae family (mint family) or Valerianaceae family.
• Pregnancy and breastfeeding (lactation).
• Children under 12 years of age due to the risk of severe local irritation and systemic effects.

Drug Interactions

Formal interaction studies have not been conducted. Exercise caution with concurrent use of other central nervous system depressants (e.g., alcohol, sedatives, tranquilizers), as valerian may potentiate sedation.

Avoid concurrent topical application of other products on the same area to prevent increased risk of local irritation or unpredictable effects.

Overdose

Ingestion of the product is dangerous. Camphor is toxic if swallowed and can cause serious symptoms including nausea, vomiting, abdominal pain, agitation, confusion, seizures, and respiratory depression.

In case of accidental ingestion, seek immediate medical attention. Do not induce vomiting. Treatment is symptomatic and supportive.

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 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 25°C (77°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.