COMPOSITION:
EDTA disodium salt (15%), urea peroxide 10%, excipients.
INTENDED USE
ENDO-PREP CREAM is intended for chemo-mechanical root canal preparation.
By flushing out calcium and magnesium ions, EDTA disodium salt in the formulation softens the superficial dentin layer making it easier to remove, clear blockages and shaping the canals. Abundant foam created as a result of the reaction between urea peroxide and NaOCl allows removing debris remaining and dentine from the prepared canal.
Lubricating substances in the product facilitate the introduction of the tool into the duct and minimize the possibility of breaking the tool in the canal.
CONTRAINDICATIONS
Do not use for patients who are hypersensitive to the product components. Do not leave ENDO-PREP CREAM in the canal or the tooth chamber between visits. This can lead to excessive softening of dentin.
WARNINGS AND PRECAUTIONS
Caution is advised when preparing the canal close to the apex area, as the tool may cause perforation of the canal.
The ENDO-PREP CREAM product has cytotoxic potential. EDTA can adversely affect the bonding strength of dentin to tooth restoration materials. Endodontic treatment may involve temporary postoperative pain.
Do not use the product immediately before/after rinsing with chlorhexidine digluconate, otherwise a white milky residue will form – use purified water for rinsing.
During root canal preparation, avoid excessively strong stream of sodium hypochlorite, as this may result in irritation of the periapical tissues. EDTA contained in the product neutralises the effect of NaOCl.
Causes skin irritation. Causes serious eye damage. In case of contact rinse with plenty of water. Seek medical advice if irritation doesn’t stop. If swallowed, do not induce vomiting. Drink plenty of water.
Seek medical advice.
Use a cofferdam, disposable gloves, safety goggles/visors and protective clothing when handling the product. Keep out of reach of children.
Any serious incident involving the product should be reported to the manufacturer and the competent authority of the State in which the user or patient is domiciled.
STORAGE
Store in original packaging between 2-15°C. Expiry date is placed on the main container. Once container is open, the expiry date does not change if the container is securely closed after each use.
TRANSPORT
The product can be shipped for a maximum of 10 days under 40°C. Short-distance shipping and handling within the recommended temperature range does not affect the safety and efficacy of the product throughout its shelf life.
HANDLING THE PRODUCT CONTAINER
Empty containers should be disposed of responsibly or returned to the manufacturer.
PACKAGING
ENDO-PREP CREAM: Syringe containing 2 mL, 5 mL or 10 mL of preparation, disposable applicators (2 pcs).
ENDO-PREP CREAM MEGA PACK: 3 syringes of the preparation (each containing 10 ml of the product), disposable applicators (4 pcs).
BEFORE USE PLEASE READ THE ATTACHED INSTRUCTIONS CAREFULLY
TO BE USED BY DENTIST ONLY
