CHEMICAL PRODUCTS SAFETY INFORMATION SHEET - FISPQ PROPHYLAXIS:
1. PRODUCT AND COMPANY IDENTIFICATION
COMPANY NAME: FORMADEN INDÚSTRIA E COMÉRCIO LTDA - ME
CNPJ: 09.431.344 / 0001-20 - AF ANVISA: K3988H7H87LX
Address: Alameda Arpo, 1.475 - sala 2 - Ouro Fino - 83010-290 - São José dos Pinhais, Pr
Telephone: (41) 3556-3988 - e-mail: email@example.com
2. PRODUCT INFORMATION
PRODUCT NAME: PROPHYLAXIS: SODIUM BICARBONATE
FINISHING AND POLISHING MATERIAL: 2101272
REGISTRATION AT ANVISA: 8526549002
NATIONAL MEDICAL USE MATERIAL REGISTRATION: 8030
VALIDITY: 5 YEARS
ANVISA REGISTRATION: 80526549002
3. WAYS OF PRESENTATION
• 250g pot - white PET, with screw cap and seal that indicates the violation; product label printed by screen printing process, directly on the jars;
• 40g Sachet - Aluminized Envelope sealed in an electric sealer; adhesive label on coated paper, printed in graphics.
4. COMPOSITION AND INFORMATION ON INGREDIENTS
SODIUM BICARBONATE, SILICIC ANHYDRIDE and FLAVORIZERS (AROMAS)
• Main substance: NaHCO3
• Physical state: white and odorless solid
• Solubility: soluble in water and ethyl alcohol
• PH: 8.3
• Bulk density: 0.9 to 1.1 g / ml
• Melting point: 60º C
• Sodium bicarbonate: Pharmaceutical or food grade with 106 fina extra fine granulometry or ABNT 140 mesh with maximum retention of 10%;
5. INDICATION OF USE AND ACTION
PROPHYLAXIS Sodium Bicarbonate is indicated for dental prophylaxis and plaque removal. It is manufactured with raw materials of high purity, with humidity control and granulometry, providing continuous blasting.
The use of PROPHYLAXIS in dental prophylaxis through the blasting method removes dark stains on the teeth, caused by the consumption of coffee, teas, cigarettes and other substances, as long as these stains are associated with plaque and not with calculus.
The product is for exclusive dental use, by a professional qualified to follow the instructions for use contained in the blasting equipment manufacturer's manual and the PROPHYLAXIS manufacturer's instructions.
6. INSTRUCTIONS FOR USE
• Product developed with granulometry suitable for use in blasting equipment for dental prophylaxis.
• Strictly follow the instructions for use contained in your blasting equipment manufacturer's manual.
• Clean the tank before filling it with PROPHYLAXIS Sodium Bicarbonate.
• The handpiece of the blasting equipment must be kept at a distance between 1 to 5 mm from the tooth, depending on the degree of difficulty in removing the plaque and at an angle of 30 ° to 60 °.
7. AGAINST INDICATION
• Spacing three months between each prophylaxis with sodium bicarbonate for each patient;
• Baking soda dehydrates the lips; Use liquid petroleum jelly or cocoa butter.
• Use the sodium bicarbonate jet sparingly on acrylic veneers of the metaloplastic crowns, as it can cause unnecessary wear.
• The use of sodium bicarbonate jet is contraindicated for patients with periodontal diseases, with root and dentin exposure. As well as for patients with respiratory changes, who have a history of sensitivity to this product, with serious kidney complications or who undergo hemodialysis;
• Sodium Bicarbonate must not be ingested or inhaled.
• The product has no adverse effect when in contact with the skin.
• Contact with eyes causes irritation.
• Substance classified by the UN as not dangerous.
8. FIRST AID MEASURES
Ingestion of high doses causes nausea and vomiting. Search for a doctor.
Accidental inhalation remove to ventilated area
If in contact with eyes, wash with plenty of water for 15 minutes. Consult an ophthalmologist
9. FIRE-FIGHTING MEASURES
Not applicable. Non-flammable substance.
10. HANDLING AND STORAGE
The product must be handled and stored under normal conditions.
It is advisable to use gloves and a mask during handling.
In case of accidental spillage, collect the product with sweeping and / or vacuuming with cleaning equipment.
11. EXPOSURE CONTROL AND PERSONAL PROTECTION
It is recommended for the professional to use protective glasses, mask, latex gloves, cap and clothing against particles;
It is recommended for the patient, the use of protectors, the rubber dam and the use of aspiration;
Clothes made of cotton or synthetic fabrics can normally be used when handling the product.
12. STABILITY AND REACTIVITY
Under normal environmental conditions, the substance is stable and requires no further care, in addition to those mentioned in the previous sections.
Releases carbon dioxide (CO2) when in contact with acids.
13. TOXICOLOGICAL INFORMATION
- Awareness: No data available
- Chronic Toxicity: No data available.
- Specific effects: No data available
14. ECOTOXICOLOGICAL INFORMATION
The product does not cause significant damage to the environment (soil, rivers and atmosphere).
15. TREATMENT AND DISPOSAL INFORMATION
Recommended treatment and disposal methods applied to:
- Product: proper disposal according to the applicable regulations;
- Used packaging: dispose of in an appropriate place.
16. TRANSPORT INFORMATION
Non-hazardous product according to transport regulations.
FORMADEN INDÚSTRIA E COMERCIO LTDA - ME
Technical Responsible: Silvana da Silva Valter