Cholisal^® Dental (Gel) Instructions for Use

Marketing Authorization Holder

VALEA NT, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

Contact Information

BAUSH HEALTH LLC (Russia)

Dosage Form

Cholisal® Dental

Oral care gel: 15 g tube

Dosage Form, Packaging, and Composition

Oral care gel .

Composition water, propylene glycol, hypromellose, methylparaben, peppermint oil, propylparaben, disodium edetate, aprotinin, sodium hydroxide.

15 g – aluminum tubes (1) – cardboard boxes.

Therapeutic Category

Oral hygiene product

Properties

A cosmetic product that contains aprotinin, which helps neutralize the effects of adverse factors causing inflammation, swelling, pain, and bleeding of the gums.

It can be used as an oral care product, in combination with other drugs for diseases of the oral mucosa.

It supports gum health and helps protect them to prevent bleeding, swelling, and pain.

Scope of Application

As a cosmetic product for oral care to prevent swelling, bleeding, and pain of the gums.

Indications

• Use as a cosmetic product for oral care to prevent swelling, bleeding, and pain of the gums.
• Support gum health and help protect them from adverse factors causing inflammation.
• Use in combination with other drugs for diseases of the oral mucosa.

ICD codes

Dosage Regimen

Apply a strip of gel approximately 1 centimeter long to the affected gum area.

Gently massage the gel into the gum with a clean finger.

Use this product two to four times daily, preferably after meals and before bedtime.

Do not eat or drink for 30 minutes after application to ensure the gel remains in contact with the affected tissue.

Adverse Reactions

Allergic reactions are possible.

These may include localized skin reactions such as rash, itching, or redness at the application site.

Discontinue use immediately and consult a healthcare professional if any signs of hypersensitivity occur.

Drug Interactions

No specific drug interactions are known.

As a topical cosmetic product, systemic absorption of active ingredients is minimal.

Inform your healthcare provider about all other oral care products you are using.

Contraindications

• Hypersensitivity to any component of the cosmetic product.
• Children under 14 years of age.

Overdose

Overdose is unlikely due to topical application and low systemic absorption.

Excessive topical application may increase the risk of local adverse reactions.

If accidentally ingested in large quantities, seek medical attention or contact a Poison Control Center immediately.

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.