PhysiciansCare 51014 User Manual

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SAFETY DATA SHEET
SECTION 1: PRODUCT AND COMPANY IDENTIFICATION
Product Identifier #007
Product Use Topical Antiseptic and Analgesic Skin Cream
Manufacturer Water Jel Technologies LLC 50 Broad Street Carlstadt, New Jersey 07072
Telephone 201-507-8300 E-mail Address www.waterjel.com Emergency Telephone 1-800-275-3433 FAX Number 201-507-8325
Issue Date: 08-25-2015
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 E xter nal Use Only. When using this product, avoid contact wi th th e eyes. Do not use on large areas of the body or on broken, blistered or oozing skin.
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.
If swallowed, g et medical help or contact a Poi so n Control Center immediately.
Physical Hazards: Thi s mixture does not meet the classificati o n cr iteria according to OSHA Hazcom 2012. Health Hazards: This mixture does not meet the classification criteria according to OSHA Hazcom 2012. Environmental Hazards: This mixture does not meet the classification criteria according to OSHA Hazcom 2012. OSHA Defined Hazards: This mixture does not meet the classi fi cation criteria according to OSHA Hazcom 2012.
Label Elements: Hazard Symbol: None
Signal Word: None Hazard Statement: The mixture does not meet the criteria for classificatio n . Precautionary Statement: Prevention None required according to OS HA Hazcom 2012. Response None required according to OS HA Hazcom 2012. Storage None required according to OSHA Hazcom 2012. Disposal None requ i r ed acco rd ing to OSHA Hazcom 2012.
Hazards not otherwise Classified (HNOC): None known.
Supplemental Information: None.
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SAFETY DATA SHEET
Route of Entry:
Skin Contact: May cause irritation, redness, infl am mation or dryness. Skin Absorption: No adverse conditions expected. Eye Contact: Flush eyes with clear runnin g water for a minimum of 15 m inutes; if irritation persists, seek medical attention. Inhalation: Not expected due to form. Ingestion: May cause irritation of the digestive tract.
SECTION 3: COMPOSITION/INFORMATION ON INGREDI E NTS
Mixtures
Chemical Name Common Name and Synonyms CAS Number %
Benzalkonium Chloride 63449-41-2 0.13
Lidocaine HCl 6108-05-0 0.5
Glycerin 1, 2, 3, Propanetriol 56-81-5 Proprietary
Triethanolamine Trolamine 102-71-6 Proprietary
Propylene Glycol 1, 2, 3, P ro p an etriol 2-Hydroxypropanol 57-55-6 Proprietary
_ SECTION 4: F IRST AID MEAS URES
Skin Contact: Wash off with war m water and soap. Get medical attenti on 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 vi cti m to fresh air. Ingestion : May cause irritation of the digesti ve tract.
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 invo lve 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 1 Fir e 0 Reactivity 0 Other NA
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SAFETY DATA SHEET
SECTION 6: ACCIDENTAL RELEASE MEASURES
Personal precautions, Protective equipment and Emergency procedures: Wear appr o p riate personal protective equipmen t.
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: Fl u sh 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 oth er chemicals out of the reach of child ren .
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
Glycerin (CAS 57-55-8) NE 5 mg/m3 Aerosol
Propylene Glycol (CAS 57-55-6) 10 mg/m3 NE NE Aerosol
Triethanolamine (CAS 102-71-6) 5 mg/m3 NE NE Aerosol
Biological Limit Values: No biological Exposure limits noted for the ingredients.
Ventilation and Engineering Controls: Ensure adequate venti lation.
Personal Protective Equi p m en t: None required under normal conditions Hand Protection: None required under normal conditions. Eye and Face Protection: E ye 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 nearb y and ready to use.
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SAFETY DATA SHEET
SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES
Appearance: Cream. Physical State: Cream. Form: Cream. Color: White, homogeneous. Odor: Slightly fatty odor.
pH: No informatio n available. Boiling Point: 275°F Melting Point: No information available. Flash Point: N/A Explosive Properties: No information available. Oxidizing Properties: No information available. Specific Gravity: 0.81 Water Solubility: Miscible. Partition Coefficien t: No information available. Viscosity: No infor m ation available. Vapor Pressure (mm Hg): No information available. Vapor Density (Air=1): No in fo rmation available. Evaporation Rate: No i n fo rmation available. % Volatile: No information avail able.
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.
SECTION 11: 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 ski n . Accidental ingestion may be harmful. Although unlikely, irritation can i r ritate the respiratory system. Eye contact will cause irritation. Chronic: NE
Target Organs: Acute Chronic: Occupational exposure: S kin.
Inhalation: Mist may slightly irritate the nose, throat and lungs. Symptoms are generally alleviated upon breathing fresh air.
: Occupational exposure: Skin, eyes.
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SAFETY DATA SHEET
Skin Contact: Skin contact may cause burning sensation, stinging, itching and tingling.
Eye Contact: Eye contact can cause irritation, stinging, red n ess an d 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, vomiti n g an d d iarrhea.
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:
Propylene Glycol (CAS 57-55-6)
• Oral (r at): 2200mg/k
• Dermal : (rabbit) 20800 mg/k
Triethanolamine):
• Oral (rat): 6110 mg/kg
• Dermal: (rabbit): >19870 mg/k
Glycerin (Mist):
• Oral (r at): 12,600 mg/kg
• Sub cu taneo u s (rat): Not Available
Carcinogenicity: Not classified as a human car ci n o g en by IARC or ACGIH.
Reproductive Toxicity:
Mutagenic/Embryo Toxicity humans. Teratogenicity: Not available. Reproductive Toxicity: Not available.
SECTION 12: ECOLOGICAL INFORMATION
No specific information i s cu rr ently 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:
Propylene Glycol:
EC50 Green Algae (Desmodesmus subspicatus) 19000 mg/l 96 hours EC50 Water Flea (Daphnia magna) 43500 mg/l 48 hours LC 50 Fathead Minnow (Pimephales promelas) 46500 mg/l 96 hours
: The components of this product are not reported to cause mutagenic or embryonic effects in
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SAFETY DATA SHEET
Triethanolamine:
EC50 Green Algae (Desmodesmus subspicatus) 512 mg/l 72 h o u rs NOEC Water Flea (Daphnia m ag n a) 16 m g /l 21 days LC 50 Fathead Minnow (P imephales promelas) 11800 mg/l 96 hours
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: DISP OSAL CONSIDERATIONS
Disposal Instructions: Collect or d ispose in sealed containers at licen sed waste disposal site. Dispose in accordance with local, state and federal regulatio n s.
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.
_________________________________________________________________________________________________________ SECTION 15: REGULATORY INFORMATION
U.S. Federal Regulations: TSCA (TOXIC SUBSTANCE CONTROL ACT): Not regulated.
CERCLA (COMPREHENSIVE RESPONSE COMP ENSATION, 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:
This product does not contain any chemicals known to the State of California to cause cancer, birth, or any other reproductive defects.
New Jersey RTK: Glycerin (CAS 56-81-5) Propylene Glycol (CAS 57-55-6) Triethanolamine (CAS 102-71-6)
Massachusetts RTK: Triethanolamine (CAS 102-71-6)
Pennsylvania RTK: Propylene Glycol (CAS 57-55-6) Triethanolamine (CAS 102-71-6)
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SAFETY DATA SHEET
INTERNATIONAL REGULATIONS:
SECTION 16: OTHER INFORMATION
Issue Date: 08-25-2015
Version: 02
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 handli n g , u se, processing, storage, transportation, disposal and release and i s n o t to be considered a warranty or quality specification. The in for mation relates only to the specific material designated an d may not be valid for such material used in combination with any other materials or p ro cesses.
Country or Region Inventor y Name Listed Australia Australia Inventory of Chemical Substances No Canada Dom esti c Substance List (DSL) Yes Canada Non-Domestic Substance List (NDSL) No China: Inventory of Existing Chemi cal Substances In China (IECSC) Yes Europe European Li st o f Notified Chemical Substances (EINECS) Yes Europe European List of Notified Chemi cal Substances (ELINCS) No Japan Inventor y of Existing and New Chemical Substances (ENCS) No Korea Existing Chemicals List (ECL) Yes New Zealand New Zealand Inventory Yes Philippines Philip p ine Inventory of Chemicals and Chemical Substan ces (P ICCS) No United States & Puerto Rico Toxic Substance Control Act (TSCA) Inventory No
Note: A “Yes” indicates that all co mponents comply with the inventory requirements admi nistered 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.
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