Traxodent® Gel FS Safety Data Sheet

Section 1: Identification

1.1. Identification

Product form: Hemostatic agent

Trade name: Traxodent® Gel FS

1.2. Recommended use and restrictions on use

Use of the substance/mixture: Hemostatic gel that controls bleeding of gums and tissue during dental procedures

Restrictions on use: For professional use only

1.3. Supplier

Manufacturer: Inter-Med, Inc.

2200 South Street
Racine, WI 53404

Tel: +1-262-636-9755

1.4. Emergency telephone number

800-424-9300 (North America) / +1 (703) 527-3887 (International)

Section 2: Hazard(s) identification

2.1. Classification of the substance or mixture

GHS-US classification:

• Skin corrosion/irritation Category 1: Causes severe skin burns and eye damage
• Serious eye damage Category 1: Causes serious eye damage
• Serious eye irritation Category 2A: Causes serious eye irritation

2.2. GHS Label elements, including precautionary statements

GHS US labeling:

Hazard pictograms (GHS US): [Corrosion symbol] ⚠️

Signal word (GHS US): Danger

Hazard statements (GHS US): Causes severe skin burns and eye damage

Precautionary statements (GHS US):

• Do not breathe mist, vapors.
• Wash hands thoroughly after handling.
• Wear eye protection, protective gloves.
• If swallowed: rinse mouth. Do NOT induce vomiting.
• If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.
• If inhaled: Remove person to fresh air and keep comfortable for breathing.
• If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
• Immediately call a doctor, a POISON CENTER.
• Wash contaminated clothing before reuse.
• Store locked up.
• Dispose of contents/container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

2.3. Other hazards which do not result in classification

No additional information available

2.4. Unknown acute toxicity (GHS US)

Not applicable

Section 3: Composition/Information on Ingredients

3.1. Substances

Not applicable

3.2. Mixtures

Full text of hazard classes and H-statements: see section 16

Section 4: First-aid measures

4.1. Description of first aid measures

First-aid measures after inhalation: Remove person to fresh air and keep comfortable for breathing. Give artificial respiration if necessary. If you feel unwell, seek medical advice.

First-aid measures after skin contact: Wash off immediately and plentifully with water for at least 15 minutes. Take off immediately all contaminated clothing and wash it before reuse.

First-aid measures after eye contact: In case of eye contact, immediately rinse with clean water for at least 15 minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

First-aid measures after ingestion: Rinse mouth. Do not induce vomiting. Get medical advice/attention.

4.2. Most important symptoms and effects (acute and delayed)

Symptoms/effects after inhalation: Inhalation of airborne droplets or aerosols may cause irritation of the respiratory tract.

Symptoms/effects after skin contact: Causes severe burns.

Symptoms/effects after eye contact: Causes serious eye damage.

Symptoms/effects after ingestion: May cause burns or irritation of the linings of the mouth, throat, and gastrointestinal tract.

4.3. Immediate medical attention and special treatment, if necessary

Treat symptomatically.

Section 5: Fire-fighting measures

5.1. Suitable (and unsuitable) extinguishing media

Suitable extinguishing media: Suitable extinguishing media for the surrounding fire should be used.

Unsuitable extinguishing media: None known.

5.2. Specific hazards arising from the chemical

Fire hazard: No direct fire hazard.

Explosion hazard: No direct explosion hazard.

5.3. Special protective equipment and precautions for fire-fighters

Firefighting instructions: Exercise caution when fighting any chemical fire.

Protection during firefighting: Do not attempt to take action without suitable protective equipment. Self-contained breathing apparatus. Complete protective clothing.

Section 6: Accidental release measures

6.1. Personal precautions, protective equipment and emergency procedures

6.1.1. For non-emergency personnel

Protective equipment: Use personal protective equipment as required. For further information refer to section 8: "Exposure controls/personal protection".

Emergency procedures: Evacuate unnecessary personnel. Contain spills.

6.1.2. For emergency responders

Protective equipment: Do not attempt to take action without suitable protective equipment. In case of inadequate ventilation wear respiratory protection.

6.2. Environmental precautions

Avoid release to the environment.

6.3. Methods and material for containment and cleaning up

Methods for cleaning up: Soak up spills with inert solids, such as clay or diatomaceous earth as soon as possible. Collect spillage.

Other information: Dispose of materials or solid residues at an authorized site. For further information refer to section 8: "Exposure controls/personal protection". For disposal of residues refer to section 13: "Disposal considerations"

Section 7: Handling and storage

7.1. Precautions for safe handling

Precautions for safe handling: Ensure good ventilation of the work station. Wear personal protective equipment. Prevent formation of aerosols.

Hygiene measures: Do not eat, drink or smoke when using this product. Always wash hands after handling the product. Wash contaminated clothing before reuse. Handle in accordance with good industrial hygiene and safety practice.

7.2. Conditions for safe storage, including any incompatibilities

Storage conditions: Store in a well-ventilated place. Keep cool.

Incompatible materials: Strong acids, strong bases and strong oxidants.

Section 8: Exposure controls/personal protection

8.1. Control parameters

8.2. Appropriate engineering controls

Appropriate engineering controls: Ensure good ventilation of the work station. Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.

Environmental exposure controls: Avoid release to the environment.

8.3. Individual protection measures/Personal protective equipment

Hand protection: Impermeable protective gloves

Eye protection: Safety glasses with side shields (tightly sealed)

Skin and body protection: Long sleeved protective clothing

Section 9: Physical and chemical properties

9.1. Information on basic physical and chemical properties

9.2. Other information

No additional information available

Section 10: Stability and reactivity

10.1. Reactivity: The product is non-reactive under normal conditions of use, storage and transport.

10.2. Chemical stability: Stable under ordinary conditions of use and storage.

10.3. Possibility of hazardous reactions: Reacts with peroxides. Avoid mixing with peroxides.

10.4. Conditions to avoid: High heat.

10.5. Incompatible materials: Strong acids, strong bases and oxidizing agents.

10.6. Hazardous decomposition products: No hazardous decomposition products known at room temperature.

Section 11: Toxicological information

11.1. Information on toxicological effects

Acute toxicity (oral): Not classified (Based on available data, the classification criteria are not met)

Acute toxicity (dermal): Not classified (Based on available data, the classification criteria are not met)

Acute toxicity (inhalation): Not classified (Based on available data, the classification criteria are not met)

Skin corrosion/irritation: Causes severe skin burns and eye damage. pH: < 1

Serious eye damage/irritation: Causes serious eye damage. pH: < 1

Respiratory or skin sensitization: Not classified (Based on available data, the classification criteria are not met)

Germ cell mutagenicity: Not classified (Based on available data, the classification criteria are not met)

Carcinogenicity: Not classified (Based on available data, the classification criteria are not met)

Reproductive toxicity: Not classified (Based on available data, the classification criteria are not met)

Specific target organ toxicity - single exposure: Not classified (Based on available data, the classification criteria are not met)

Specific target organ toxicity - repeated exposure: Not classified (Based on available data, the classification criteria are not met)

Aspiration hazard: Not classified (Based on available data, the classification criteria are not met)

Viscosity, kinematic: No data available

Likely routes of exposure: Inhalation. Ingestion. Skin and eye contact.

Symptoms/effects after inhalation: Inhalation of airborne droplets or aerosols may cause irritation of the respiratory tract.

Symptoms/effects after skin contact: Causes severe burns.

Symptoms/effects after eye contact: Causes serious eye damage.

Symptoms/effects after ingestion: May cause burns or irritation of the linings of the mouth, throat, and gastrointestinal tract.

Section 12: Ecological information

12.1. Toxicity

Ecology - general: This material has not been tested for environmental effects.

Persistence and degradability

No additional information available

Bioaccumulative potential

No additional information available

Mobility in soil

No additional information available

Other adverse effects

No additional information available

Section 13: Disposal considerations

Disposal methods

Waste treatment methods: Dispose of contents/container in accordance with licensed collector's sorting instructions.

Section 14: Transport information

Department of Transportation (DOT)

In accordance with DOT:

Transport document description: UN3264 Corrosive liquids, Acidic, Inorganic, n.o.s. (Ferric Sulfate)

UN-No. (DOT): UN3264

Proper Shipping Name (DOT): Corrosive liquids, n.o.s. (Ferric Sulfate)

Class (DOT): 8 - Class 8 - Corrosive material 49 CFR 173.136

Packing group (DOT): II - Medium Danger

Hazard labels (DOT): 8 - Corrosive [Corrosion symbol] 8

DOT Packaging

Non Bulk (49 CFR 173.xxx): 202

Bulk (49 CFR 173.xxx): 242

DOT Special Provisions (49 CFR 172.102):

B2 - MC 300, MC 301, MC 302, MC 303, MC 305, and MC 306 and DOT 406 cargo tanks are not authorized.

IB2 - Authorized IBCs: Metal (31A, 31B and 31N); Rigid plastics (31H1 and 31H2); Composite (31HZ1). Additional Requirement: Only liquids with a vapor pressure less than or equal to 110 kPa at 50 C (1.1 bar at 122 F), or 130 kPa at 55 C (1.3 bar at 131 F) are authorized.

T11 - 6 178.274(d)(2) Normal; 178.275(d)(3)

TP2 - a. The maximum degree of filling must not exceed the degree of filling determined by the following formula: (Description of image: The formula relates filling degree to transport temperature, filling temperature, and coefficient of cubical expansion). b. For liquids transported under ambient conditions, the formula (Description of image: formula for density calculation based on temperature) may be used.

TP27 - A portable tank having a minimum test pressure of 4 bar (400 kPa) may be used provided the calculated test pressure is 4 bar or less based on the MAWP of the hazardous material, as defined in 178.275 of this subchapter, where the test pressure is 1.5 times the MAWP.

DOT Packaging Exceptions (49 CFR 173.xxx): 154

DOT Quantity Limitations Passenger aircraft/rail (49 CFR 173.27): B - The material may be stowed "on deck" or "under deck" on a cargo vessel and on a passenger vessel carrying a number of passengers limited to not more than the larger of 25 passengers, or one passenger per each 3 m of overall vessel length; and "On deck only" on passenger vessels in which the number of passengers specified in paragraph (k)(2)(i) of this section is exceeded.

DOT Quantity Limitations Cargo aircraft only (49 CFR 175.75): 40 - Stow "clear of living quarters"

DOT Vessel Stowage Location: 154

DOT Vessel Stowage Other: No supplementary information available.

Emergency Response Guide (ERG) Number: 154

Transportation of Dangerous Goods (TDG)

Transport document description: UN3264 Corrosive liquids, Acidic, Inorganic, n.o.s. (Ferric Sulfate)

UN-No. (TDG): UN3264

Proper Shipping Name (Transportation of Dangerous Goods): Corrosive Liquid, N.O.S.

TDG Primary Hazard Classes: 8 - Class 8 - Corrosives

Packing group: II - Medium Danger

TDG Special Provisions: 16 - (1) The technical name of at least one of the most dangerous substances that predominantly contributes to the hazard or hazards posed by the dangerous goods must be shown, in parentheses, on the shipping document following the shipping name in accordance with clause 3.5(1)(c)(ii)(A) of Part 3 (Documentation). The technical name must also be shown, in parentheses, on a small means of containment or on a tag following the shipping name in accordance with subsections 4.11(2) and (3) of Part 4 (Dangerous Goods Safety Marks). (2) Despite subsection (1), the technical name for the following dangerous goods is not required to be shown on a shipping document or on a small means of containment when Canadian law for domestic transport or an international convention for international transport prohibits the disclosure of the technical name: (a)UN1544, ALKALOID SALTS, SOLID, N.O.S. or ALKALOIDS, SOLID, N.O.S; (b)UN1851, MEDICINE, LIQUID, TOXIC, N.O.S; (c)UN3140, ALKALOID SALTS, LIQUID, N.O.S. or ALKALOIDS, LIQUID, N.O.S; (d)UN3248, MEDICINE, LIQUID, FLAMMABLE, TOXIC, N.O.S; or (e)UN3249, MEDICINE, SOLID, TOXIC, N.O.S. An example in Canada is the "Food and Drugs Act". (3) Despite subsection (1), the technical name for the following dangerous goods is not required to be shown on a small means of containment: (a)UN2814, INFECTIOUS SUBSTANCE, AFFECTING HUMANS; or (b)UN2900, INFECTIOUS SUBSTANCE, AFFECTING ANIMALS. SOR/2014-306

Explosive Limit and Limited Quantity Index: 1L

Passenger Carrying Road Vehicle or Passenger Carrying Railway Vehicle Index: 1L

Transport by sea (IMDG)

Transport document description (IMDG): UN3264 Corrosive liquids, Acidic, Inorganic, n.o.s. (Ferric Sulfate), 8, II UN

UN No. (IMDG): 3264

Proper Shipping Name (IMDG): CORROSIVE LIQUID, N.O.S.

Class (IMDG): 8 - Corrosive substances

Packing group (IMDG): II - substances presenting medium danger

Air transport (IATA)

Transport document description (IATA): UN3264 Corrosive liquids, Acidic, Inorganic, n.o.s. (Ferric Sulfate), 8, II UN

UN No. (IATA): 3264

Proper Shipping Name (IATA): Corrosive liquid, n.o.s.

Class (IATA): 8 - Corrosives

Packing group (IATA): II - Medium Danger

Section 15: Regulatory information

15.1 US Federal regulations

No additional information available

15.2 International regulations

CANADA

No additional information available

EU-Regulations

No additional information available

National regulations

Ferric Sulfate (010028-22-5)

• Listed on the AICS (Australian Inventory of Chemical Substances)
• Listed on IECSC (Inventory of Existing Chemical Substances Produced or Imported in China)
• Listed on NZIoC (New Zealand Inventory of Chemicals)
• Listed on PICCS (Philippines Inventory of Chemicals and Chemical Substances)
• Listed on the TCSI (Taiwan Chemical Substance Inventory)

US State regulations

No additional information available

Section 16: Other information

Revision date: 05 August 2025 Rev1

Full text of H-phrases:

• H314: Causes severe skin burns and eye damage
• H318: Causes serious eye damage
• H372: Causes damage to organs

SDS US (GHS HazCom 2012)

The information contained herein is based on our present knowledge. However, this information shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. Premier Dental Products Company makes no warranties, express or implied with respect to, and assumes no responsibility or liability for, the accuracy or completeness of the information contained herein. Premier Dental Products Company urges persons receiving this information to make their own determination as to the information suitability for their particular application.

0825015 Rev1