Caldent Baby (Gel) Instructions for Use

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

N01BB52 (Lidocaine in combination with other drugs)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Cetylpyridinium chloride (Rec.INN registered by WHO)

Dosage Form

Caldent Baby

Gel for application to gums (for children) 3.3 mg + 1.0 mg/g: jars or tubes 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, 100 g

Dosage Form, Packaging, and Composition

Gel for application to gums (for children) soft, homogeneous, yellowish-brown in color with a characteristic odor.

Excipients : sorbitol solution 70% non-crystallizing – 210 mg, xylitol – 140 mg, ethanol 95% – 93.6 mg, glycerol – 70 mg, hydroxyethylcellulose – 25 mg, macrogol glyceryl hydroxystearate – 10 mg, lauromacrogol 600 – 3.3 mg, macrogol 300 – 3.3 mg, sodium saccharin – 1 mg, levomenthol – 0.6 mg, herbal flavor – 4.8 mg, caramel E150 – 1 mg, sodium citrate – 8.3 mg, citric acid monohydrate – 1.05 mg, purified water – up to 1000 mg.

5 g – orange glass jars (1) – cardboard packs (1).
15 g – orange glass jars (1) – cardboard packs (1).
20 g – orange glass jars (1) – cardboard packs (1).
25 g – orange glass jars (1) – cardboard packs (1).
30 g – orange glass jars (1) – cardboard packs (1).
35 g – orange glass jars (1) – cardboard packs (1).
40 g – orange glass jars (1) – cardboard packs (1).
50 g – orange glass jars (1) – cardboard packs (1).
60 g – orange glass jars (1) – cardboard packs (1).
70 g – orange glass jars (1) – cardboard packs (1).
80 g – orange glass jars (1) – cardboard packs (1).
90 g – orange glass jars (1) – cardboard packs (1).
100 g – orange glass jars (1) – cardboard packs (1).
5 g – tubes (1) – cardboard packs (1).
10 g – tubes (1) – cardboard packs (1).
15 g – tubes (1) – cardboard packs (1).
20 g – tubes (1) – cardboard packs (1).
25 g – tubes (1) – cardboard packs (1).
30 g – tubes (1) – cardboard packs (1).
35 g – tubes (1) – cardboard packs (1).
40 g – tubes (1) – cardboard packs (1).
50 g – tubes (1) – cardboard packs (1).
60 g – tubes (1) – cardboard packs (1).
70 g – tubes (1) – cardboard packs (1).
80 g – tubes (1) – cardboard packs (1).
90 g – tubes (1) – cardboard packs (1).
100 g – tubes (1) – cardboard packs (1).

Clinical-Pharmacological Group

A drug used to facilitate teething in children

Pharmacotherapeutic Group

Anesthetics; local anesthetics; amides

Pharmacological Action

Combined preparation for topical use, contains an antiseptic agent and a local anesthetic agent.

Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds, it has bactericidal activity against gram-positive and, to a lesser extent, gram-negative bacteria. It alters the permeability of the cytoplasmic membrane of bacteria, disrupts the internal oxidative mechanisms of bacterial respiration, which leads to their death. Cetylpyridinium chloride has antifungal and antiviral activity against enveloped viruses.

Lidocaine hydrochloride is a local anesthetic from the amide group; in inflammatory processes, it relieves sore throat when swallowing. Lidocaine impairs the permeability of the cell membrane to sodium ions, which leads to anesthesia as a result of blocking the conduction of nerve impulses.

Pharmacokinetics

Cetylpyridinium chloride is practically not absorbed through the oral mucosa.

Lidocaine hydrochloride is poorly absorbed through the oral mucosa. When taken orally, it is absorbed, undergoing metabolism during the “first pass” through the liver. When taken orally, its bioavailability is about 35%. Metabolites are excreted in the urine, less than 10% of the substance is excreted unchanged.

Indications

Infectious and inflammatory diseases of the oral cavity and pharynx: pharyngitis; laryngitis; catarrhal tonsillitis; stomatitis; ulcerative gingivitis; tonsillitis (as an auxiliary agent).

Pain during teething, gum irritation.

ICD codes

Dosage Regimen

Apply the gel topically to the child’s inflamed or teething gums.

Use a pea-sized amount (approximately 0.25-0.5 g) per application.

Apply with a clean fingertip or a cotton swab, gently massaging the gel into the gum area.

Administer every 3-4 hours as needed for pain relief, but do not exceed 6 applications in 24 hours.

Use only after feeding the child; avoid application immediately before meals.

Ensure the child does not eat or drink for at least 30 minutes after application to maintain local effect.

Do not use for more than 7 consecutive days without consulting a physician.

Discontinue use and seek medical advice if irritation, swelling, or other adverse reactions occur.

This product is for external use only in the oral cavity; avoid contact with eyes.

For children under 1 year of age, use strictly under medical supervision.

Adverse Reactions

From the digestive system: rarely – nausea; very rarely – diarrhea.

From the skin and subcutaneous tissues: very rarely – skin rash, itching.

Local reactions rarely – local irritation of the oral mucosa and throat.

Contraindications

First trimester of pregnancy; breastfeeding period; children under 5 months of age, children under 6 years of age (for dosage forms intended for children over 6 years of age and adults), hypersensitivity to the components of the drug.

With caution

Open wounds of the oral mucosa.

Use in Pregnancy and Lactation

Use is contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible under medical supervision, if the expected benefit to the mother outweighs the potential risk to the fetus.

Not recommended for use during breastfeeding.

Pediatric Use

Contraindicated for use in children under 5 months of age; in children under 6 years of age (for dosage forms intended for children over 6 years of age and adults).

Special Precautions

Should not be taken immediately before meals and simultaneously with milk. Simultaneous intake with milk and food may reduce the local antiseptic and anesthetic effects.

Alcohol increases the absorption of cetylpyridinium chloride, therefore alcohol should not be consumed during treatment.

Cetylpyridinium chloride slows wound healing.

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

Rx Only

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.