Neomycin Antibiotic Ointment

Water Jel Technologies LLC

Revision date : 2019-12-04

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GHS07
Health risk rating 4
Safety risk rating 4
Environmental risk rating 5

Note: Ingredients listed on restricted chemical lists

EC/CAS

57-11-4

Name of the chemical

stearic acid

Concentration

5-10

EC/CAS

56-81-5

Name of the chemical

glycerol

Concentration

1-5

EC/CAS

57-55-6

Name of the chemical

1,2-propanediol

Concentration

0.5-1.5

General Information

Revision date

2019-12-04

Product name

Neomycin Antibiotic Ointment

1.2.1 Relevant identified uses

Topical Antibiotic Ointment

Manufacturer Name

Water Jel Technologies LLC

Emergency telephone

1-800-275-3433

Icons in SDS

GHS07

Company Information

company name

Water Jel Technologies LLC

GHS Information

Signal word

None

Section 2

SECTION 2: Hazards identification

Emergency Overview: This product is regulated by the US FDA as an over-the-counter, monograph drug. For Consumers, consult the Drug Facts on the package for use directions and warnings information. Warnings: For External Use Only. When using this product, avoid contact with the eyes. Do not use on large areas of the body or on broken, blistered or oozing skin. Do not use if you are allergic to any of the ingredients. Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days. If swallowed, get medical help or contact a Poison Control Center immediately.

Hazard pictograms

None

Signal word

None

Hazard statements

The mixture does not meet the criteria for classification Not classified.

2.3 Other hazards

None known.

Additional information

None

Principle Routes of Exposure

Skin Contact: May cause irritation, redness, inflammation or dryness. Skin Absorption: No adverse conditions expected. Eye Contact: Direct contact with eyes may cause temporary irritation. Inhalation: Not expected due to form. Ingestion: May cause irritation of the digestive tract. _ SECTION 4: FIRST AID MEASURES Skin Contact: Wash off with warm water and soap. Get medical attention if symptoms occur. Skin Absorption: No adverse conditions expected. Eye Contact: Flush eyes with clear running water for a minimum of 15 minutes; if irritation persists, seek medical attention. Inhalation: Remove victim to fresh air. Ingestion Do not induce vomiting due to aspiration hazard. If vomiting should occur, lower head below knees to avoid aspiration. SECTION 5: FIRE-FIGHTING MEASURES Flammable: No Means of Extinction: Use extinguishing media appropriate for surrounding fire. Use water spray, foam or dry chemical. In fires involving large quantities of this product, the use of large streams of water should be avoided. Use self-contained breathing apparatus when fighting fires that involve this material. Flash Point and Method: NA Upper Flammable Limit (% by volume): NA Lower Flammable Limit (% by volume): NA Autoignition Temperature (°C): NA Explosion Data – Sensitivity to Impact: No unusual fire or explosion hazards noted. Explosion Data – Sensitivity to Static Discharge: No unusual fire or explosion hazards noted. Hazardous Combustion Products: Carbon oxides. Nitrogen Oxides (NOx). NFPA Health 0 Fire 1 Reactivity 0 Other NA SECTION 6: ACCIDENTAL RELEASE MEASURES Personal precautions, Protective equipment and Emergency procedures: Wear appropriate personal protective equipment. Methods and materials for containment and clean up: Absorb spill with vermiculite or other inert material, then place in a sealed container for chemical waste. Large Spills: Flush with plenty of water. Prevent entry into waterways, sewer, basements or confined areas. Dike for later disposal. Small Spills: Wipe up with absorbent material (e.g. cloth, fleece). Clean surface thoroughly to remove residual contamination. Environmental Precautions: Avoid discharge into drains and water sources. SECTION 7: HANDLING AND STORAGE Handling Procedures and Equipment: Keep this and other chemicals out of the reach of children.

Storage

Temperature Do not store or mix with strong acids or oxidizers. Store at room temperature. SECTION 8: EXPOSURE CONTROLS/PERSONAL PROTECTION Occupational Exposure Limits: Components ACGIH-TLVs OSHA-PELs NIOSH Form Petrolatum (CAS 8009-03-8) 5 mg/m3 5 mg/m3 TWA Mist Biological Limit Values: No biological Exposure limits noted for the ingredients. Ventilation and Engineering Controls: Ensure adequate ventilation. Personal Protective Equipment: None required under normal conditions Hand Protection: None required under normal conditions. Eye and Face Protection: Eye protection, as necessary to prevent excessive contact. Skin Protection: None required under normal conditions. General Hygiene Considerations: Practice safe work habits. Other Protective Equipment: Eye wash stations should be nearby and ready to use. SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES Appearance: Ointment. Physical State: Ointment. Form: Ointment. Color: White to off white. Odor: Slightly fatty odor. pH: No information available. Boiling Point: >200°F closed cup Melting Point: No information available. Flash Point: N/A Explosive Properties: No information available. Oxidizing Properties: No information available. Specific Gravity: 0.87 Water Solubility: Insoluble. Partition Coefficient: No information available. Viscosity: No information available. Vapor Pressure (mm Hg): No information available. Vapor Density (Air=1): No information available. Evaporation Rate: No information available. % Volatile: No information available. SECTION 10: STABILITY AND REACTIVITY Reactivity: The product is stable and non-reactive under normal conditions of use. Chemical Stability: Stable at normal conditions. Possibility of Hazardous Reactions: Hazardous polymerization does not occur. Conditions to Avoid: Extreme heat. Materials to Avoid Strong oxidants and strong acids. Hazardous Decomposition Products: Carbon monoxide, carbon dioxide. Hazardous Polymerization: Will not occur.

TOXICOLOGICAL INFORMATION

Symptoms of Overexposure by Route of Exposure: The health hazard information provided is for handling this product in an occupational setting. Effects of Acute and Chronic Exposure: Acute: The primary health effect that may be experienced in an occupational setting is mild irritation of contaminated skin. Accidental ingestion may be harmful. Although unlikely, irritation can irritate the respiratory system. Eye contact will cause irritation. Chronic: NE Target Organs: Acute Occupational exposure Skin Chronic Occupational exposure Skin Inhalation: Mist may slightly irritate the nose, throat and lungs. Symptoms are generally alleviated upon breathing fresh air. Skin Contact: Skin contact may cause burning sensation, stinging, itching and tingling. Eye Contact: Eye contact can cause irritation, stinging, redness and tearing. Ingestion: Ingestion is not a significant route of occupational overexposure. Acute ingestion of large quantities of this product or chronic ingestion may cause adverse symptoms that may include nausea, vomiting and diarrhea. Irritancy of the Product: This product may cause mild to moderate irritation on damaged skin. Skin Sensitization: Not expected. Respiratory Sensitization: Not expected. LD50/LC50: Petrolatum (CAS 8009-03-8) • Oral: Not available. • Dermal: Not available. Carcinogenicity: Not classified as a human carcinogen by IARC or ACGIH. Reproductive Toxicity: Mutagenic/Embryo Toxicity: The components of this product are not reported to cause mutagenic or embryonic effects in humans.

Teratogenic Effects

Not available Reproductive Toxicity: This product is not expected to cause reproductive effects.

ECOLOGICAL INFORMATION

No specific information is currently available on the effect of this product on plants or animals in the environment. The product may be harmful to contaminated terrestrial and aquatic plant life in large quantities. The following aquatic toxicity data currently available for components of this product: Not expected to be harmful to aquatic organisms. Environmental Exposure Controls: Controls should be engineered to prevent release to the environment, including procedures to prevent spills, atmospheric release and release to waterways. No component of this product is known to have ozone depletion potential. SECTION 13: DISPOSAL CONSIDERATIONS

Disposal

Instructions Collect or dispose in sealed containers at licensed waste disposal site. Dispose in accordance with local, state and federal regulations. SECTION 14: TRANSPORT INFORMATION DOT Classification Not regulated for Domestic Transport IATA Classification Not regulated for International Transport IMDG Classification Not regulated for International Water Transport _________________________________________________________________________________________________________ REGULATORY INFORMATION U.S. Federal Regulations TSCA (TOXIC SUBSTANCE CONTROL ACT) Not regulated

Product definition

Product Name First Aid/ Burn Cream Other means of identification Product Code(s) FAC.00.121 Synonyms First Aid Cream; First Aid /Burn Cream Antiseptic Pain Relief with Aloe Recommended use of the chemical and restrictions on use Recommended use First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns Restrictions on use For external use only Details of the supplier of the safety data sheet Manufacturer Address WaterJel ® Technologies 50 Broad Street Carlstadt, NJ 07072 P: 201-507-8300 Emergency telephone number Emergency Telephone 800-275-3433 (8:00 am-5:00 pm EST Weekdays) Hazard(s) identification Classification

Further information

No information available.

2.1 Classification of the substance or mixture

IATA Classification: Not regulated for International Transport. IMDG Classification: Not regulated for International Water Transport. _________________________________________________________________________________________________________ SECTION 15: REGULATORY INFORMATION U.S. Federal Regulations: TSCA (TOXIC SUBSTANCE CONTROL ACT): Not regulated. CERCLA (COMPREHENSIVE RESPONSE COMPENSATION, AND LIABILITY ACT): Not listed. SARA TITLE III (SUPERFUND AMENDMENTS AND REAUTHORIZATION ACT) 304: Not regulated. SARA 311/312 HAZARD CATEGORIES: Not regulated. SARA 313 REPORTABLE INGREDIENTS: Not listed. STATE REGULATIONS: California Prop 65: Warning: This product does contain a chemical known to the State of California to cause cancer, birth, or any other reproductive defects. Neomycin Sulfate USP (CAS 1405-10-3) – internal use only – listed October 1, 1992 New Jersey RTK: Not listed. Massachusetts RTK: Petrolatum (CAS 8009-03-8) Pennsylvania RTK: Petrolatum (CAS 8009-03-8) INTERNATIONAL REGULATIONS: Country or Region Inventory Name Listed Australia Australia Inventory of Chemical Substances Yes Canada Domestic Substance List (DSL) No Canada Non-Domestic Substance List (NDSL) Yes China: Inventory of Existing Chemical Substances In China (IECSC) No Europe European List of Notified Chemical Substances (EINECS) Yes Europe European List of Notified Chemical Substances (ELINCS) No Japan Inventory of Existing and New Chemical Substances (ENCS) No Korea Existing Chemicals List (ECL) Yes New Zealand New Zealand Inventory Yes Philippines Philippine Inventory of Chemicals and Chemical Substances (PICCS) Yes United States & Puerto Rico Toxic Substance Control Act (TSCA) Inventory No Note: A “Yes” indicates that all components comply with the inventory requirements administered by the governing country. A “No” indicates that one or more components of the product are not listed or exempt from listing on the inventory administered by the governing country. SECTION 16: OTHER INFORMATION Issue Date: 06-15-2015 Version: 01 Disclaimer: The information provided in this Safety Data Sheet (SDS) is accurate to the best of our knowledge. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or processes. This safety data sheet was created pursuant to the requirements of: US OSHA Hazard Communication Standard (29 CFR 1910.1200) and Canada WHMIS 2015 which includes the amended Hazardous Products Act (HPA) and the Hazardous Products Regulation (HPR) Issuing Date 04-Dec-2019 Revision Date 04-Dec-2019 Revision Number 1 1. Identification Product identifier Product Name First Aid/ Burn Cream Other means of identification Product Code(s) FAC.00.121 Synonyms First Aid Cream; First Aid /Burn Cream Antiseptic Pain Relief with Aloe Recommended use of the chemical and restrictions on use Recommended use First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns Restrictions on use For external use only. Details of the supplier of the safety data sheet Manufacturer Address WaterJel ® Technologies 50 Broad Street Carlstadt, NJ 07072 P: 201-507-8300 Emergency telephone number Emergency Telephone 800-275-3433 (8:00 am-5:00 pm EST Weekdays) 2. Hazard(s) identification Classification Label elements

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