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Safety Data Sheet: 1. Identification of The Substance/Preparation and of The Company/Undertaking

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SAFETY DATA SHEET

Issuing Date No data available Revision Date 24-Aug-2015 Revision Number 2

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The supplier identified below generated this SDS using the UL SDS template. UL did not test, certify, or approve the substance described in this SDS, and
all information in this SDS was provided by the supplier or was reproduced from publically available regulatory data sources. UL makes no representations
or warranties regarding the completeness or accuracy of the information in this SDS and disclaims all liability in connection with the use of this information
or the substance described in this SDS. The layout, appearance and format of this SDS is © 2014 UL LLC. All rights reserved.
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1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE


COMPANY/UNDERTAKING
Product identifier

Product Name Docusate Sodium 100mg. Two Tone

Other means of identification

Synonyms None

Recommended use of the chemical and restrictions on use

Recommended Use Suppository, Laxative, Stool-Softener

Uses advised against No information available

Details of the supplier of the safety data sheet

Supplier Name PL Developments

Supplier Address 200 Hicks Street


Westbury
NY
11590
US

Supplier Phone Number Phone:516-986-1700


Fax:516-986-1774

Supplier Email jscotto@pldevelopments.com

Emergency telephone number

Company Emergency Phone 516-986-1700


Number

2. HAZARDS IDENTIFICATION
Classification

This chemical is considered hazardous by the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200).

Skin corrosion/irritation Category 2


Serious eye damage/eye irritation Category 1

GHS Label elements, including precautionary statements


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1279545 - Docusate Sodium 100mg. Two Tone Revision Date 24-Aug-2015
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Emergency Overview
Signal word Danger

Hazard Statements
Causes skin irritation
Causes serious eye damage

Appearance Red Physical state Solid containing liquid Odor Medicinal


Solid

Precautionary Statements - Prevention


Wash face, hands and any exposed skin thoroughly after handling
Wear protective gloves/protective clothing/eye protection/face protection

Precautionary Statements - Response


Specific treatment (see supplemental first aid instructions on this label)

Eyes
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
Immediately call a POISON CENTER or doctor/physician

Skin
IF ON SKIN: Wash with plenty of soap and water
If skin irritation occurs: Get medical advice/attention
Take off contaminated clothing and wash before reuse

Precautionary Statements - Storage


None

Precautionary Statements - Disposal


None

Hazards not otherwise classified (HNOC)

Not applicable

Unknown Toxicity
41.5 % of the mixture consists of ingredient(s) of unknown toxicity

Other information

May be harmful if swallowed


Harmful to aquatic life with long lasting effects

Interactions with Other Chemicals


No information available.

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1279545 - Docusate Sodium 100mg. Two Tone Revision Date 24-Aug-2015
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3. COMPOSITION/INFORMATION ON INGREDIENTS
.

Chemical Name CAS No Weight-% Trade Secret


Sodium dioctyl sulfosuccinate 577-11-7 15 - 40 *
Propylene Glycol 57-55-6 3-7 *
Glycerin 56-81-5 3-7 *
*The exact percentage (concentration) of composition has been withheld as a trade secret

4. FIRST AID MEASURES


First aid measures

General Advice Immediate medical attention is required. Show this safety data sheet to the doctor in
attendance.

Eye contact Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes. Keep
eye wide open while rinsing. Remove contact lenses, if present and easy to do. Continue
rinsing. Do not rub affected area. Seek immediate medical attention/advice.

Skin contact Wash off immediately with soap and plenty of water for at least 15 minutes. Get medical
attention if irritation develops and persists.

Inhalation Remove to fresh air. If symptoms persist, call a physician.

Ingestion Rinse mouth immediately and drink plenty of water. Never give anything by mouth to an
unconscious person. Do NOT induce vomiting. Call a physician.

Self-protection of the first aider Avoid contact with skin, eyes or clothing. Use personal protective equipment as required.
Wear personal protective clothing (see section 8).

Most important symptoms and effects, both acute and delayed

Most Important Symptoms and Burning sensation.


Effects

Indication of any immediate medical attention and special treatment needed

Notes to Physician Treat symptomatically.

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5. FIRE-FIGHTING MEASURES
Suitable Extinguishing Media
Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.

Unsuitable extinguishing media


CAUTION: Use of water spray when fighting fire may be inefficient.

Specific hazards arising from the chemical


No information available.

Uniform Fire Code Irritant: Solid

Explosion Data
Sensitivity to Mechanical Impact None.

Sensitivity to Static Discharge None.

Protective equipment and precautions for firefighters


As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full
protective gear.

6. ACCIDENTAL RELEASE MEASURES


Personal precautions, protective equipment and emergency procedures

Personal precautions Avoid contact with skin, eyes or clothing. Ensure adequate ventilation. Use personal
protective equipment as required.

Other Information Refer to protective measures listed in Sections 7 and 8.

Environmental precautions

Environmental precautions Prevent further leakage or spillage if safe to do so.

Methods and material for containment and cleaning up

Methods for containment Prevent further leakage or spillage if safe to do so.

Methods for cleaning up Pick up and transfer to properly labeled containers.

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7. HANDLING AND STORAGE


Precautions for safe handling

Handling Handle in accordance with good industrial hygiene and safety practice. Avoid contact with
skin, eyes or clothing. Do not eat, drink or smoke when using this product. Take off
contaminated clothing and wash before reuse.

Conditions for safe storage, including any incompatibilities

Storage Keep containers tightly closed in a dry, cool and well-ventilated place. Store locked up.
Keep out of the reach of children.

Incompatible Products Strong acids. Strong oxidizing agents. Strong bases.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION


Control parameters

Exposure Guidelines

Chemical Name ACGIH TLV OSHA PEL NIOSH IDLH


Glycerin TWA: 10 mg/m3 mist TWA: 15 mg/m3 mist, total
56-81-5 particulate
TWA: 5 mg/m3 mist, respirable
fraction
(vacated) TWA: 10 mg/m3 mist,
total particulate
(vacated) TWA: 5 mg/m3 mist,
respirable fraction
ACGIH TLV: American Conference of Governmental Industrial Hygienists - Threshold Limit Value OSHA PEL: Occupational Safety and Health
Administration - Permissible Exposure Limits NIOSH IDLH Immediately Dangerous to Life or Health

Appropriate engineering controls

Engineering Measures Showers


Eyewash stations
Ventilation systems

Individual protection measures, such as personal protective equipment

Eye/face protection Tight sealing safety goggles.

Skin and body protection Wear protective gloves and protective clothing. Long sleeved clothing. Impervious gloves.

Respiratory protection If exposure limits are exceeded or irritation is experienced, NIOSH/MSHA approved
respiratory protection should be worn. Positive-pressure supplied air respirators may be
required for high airborne contaminant concentrations. Respiratory protection must be
provided in accordance with current local regulations.

Hygiene Measures Avoid contact with skin, eyes or clothing. Wear suitable gloves and eye/face protection. Do
not eat, drink or smoke when using this product.

9. PHYSICAL AND CHEMICAL PROPERTIES

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1279545 - Docusate Sodium 100mg. Two Tone Revision Date 24-Aug-2015
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Physical and Chemical Properties

Physical state Solid containing liquid, Solid


Appearance Red Odor Medicinal
Color No information available Odor Threshold No information available

Property Values Remarks Method


pH No data available None known
Melting / freezing point No data available None known
Boiling point / boiling range No data available None known
Flash Point No data available None known
Evaporation Rate No data available None known
Flammability (solid, gas) No data available None known
Flammability Limit in Air
Upper flammability limit No data available
Lower flammability limit No data available
Vapor pressure No data available None known
Vapor density No data available None known
Specific Gravity No data available None known
Water Solubility Partially soluble None known
Solubility in other solvents No data available None known
Partition coefficient: n-octanol/waterNo data available None known
Autoignition temperature No data available None known
Decomposition temperature No data available None known
Kinematic viscosity No data available None known
Dynamic viscosity No data available None known
Explosive properties No data available
Oxidizing properties No data available

Other Information

Softening Point No data available


VOC Content (%) No data available
Particle Size No data available
Particle Size Distribution

10. STABILITY AND REACTIVITY


Reactivity

No data available.

Chemical stability
Stable under recommended storage conditions.
Possibility of Hazardous Reactions
None under normal processing.
Conditions to avoid
None known based on information supplied.
Incompatible materials
Strong acids. Strong oxidizing agents. Strong bases.
Hazardous Decomposition Products
None known based on information supplied.

11. TOXICOLOGICAL INFORMATION


Information on likely routes of exposure

Product Information .

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Inhalation Specific test data for the substance or mixture is not available. May cause irritation of
respiratory tract.

Eye contact Specific test data for the substance or mixture is not available. Causes serious eye
damage. (based on components). Severely irritating to eyes. May cause irreversible
damage to eyes.

Skin contact Specific test data for the substance or mixture is not available. Causes skin irritation. (based
on components). Prolonged contact may cause redness and irritation.

Ingestion Specific test data for the substance or mixture is not available. Ingestion may cause
irritation to mucous membranes. Ingestion may cause gastrointestinal irritation, nausea,
vomiting and diarrhea.

Component Information

Chemical Name Oral LD50 Dermal LD50 Inhalation LC50


Sodium dioctyl sulfosuccinate = 1900 mg/kg ( Rat ) = 10000 mg/kg ( Rabbit ) -
577-11-7
Propylene Glycol = 20000 mg/kg ( Rat ) = 20800 mg/kg ( Rabbit ) -
57-55-6
Glycerin - > 10 g/kg ( Rabbit ) -
56-81-5

Information on toxicological effects

Symptoms Erythema (skin redness). May cause redness and tearing of the eyes. May cause
blindness. Burning.

Delayed and immediate effects as well as chronic effects from short and long-term exposure

Sensitization No information available.

Mutagenic Effects No information available.

Carcinogenicity Contains no ingredient listed as a carcinogen.

Reproductive toxicity No information available.

STOT - single exposure No information available.

STOT - repeated exposure No information available.

Chronic Toxicity No known effect based on information supplied.

Target Organ Effects Respiratory system. Eyes. Skin.

Aspiration Hazard No information available.

Numerical measures of toxicity Product Information

The following values are calculated based on chapter 3.1 of the GHS document

ATEmix (oral)
3,320.00 mg/kg
ATEmix (dermal)
16,524.00 mg/kg (ATE)
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12. ECOLOGICAL INFORMATION


Ecotoxicity
Harmful to aquatic life with long lasting effects.

Chemical Name Toxicity to Algae Toxicity to Fish Toxicity to Daphnia Magna (Water
Microorganisms Flea)
Sodium dioctyl 96h LC50: 20 - 40 mg/L 48h EC50: = 36 mg/L
sulfosuccinate (Oncorhynchus mykiss) 96h
577-11-7 LC50: = 37 mg/L (Lepomis
macrochirus) 96h LC50: <
24 mg/L (Oncorhynchus
mykiss)
Propylene Glycol 96h EC50: = 19000 mg/L 96h LC50: = 51600 mg/L - 24h EC50: > 10000 mg/L
57-55-6 (Pseudokirchneriella (Oncorhynchus mykiss) 96h 48h EC50: > 1000 mg/L
subcapitata) LC50: 41 - 47 mL/L
(Oncorhynchus mykiss) 96h
LC50: = 51400 mg/L
(Pimephales promelas) 96h
LC50: = 710 mg/L
(Pimephales promelas)
Glycerin 96h LC50: 51 - 57 mL/L 24h EC50: > 500 mg/L
56-81-5 (Oncorhynchus mykiss)

Persistence and Degradability


No information available.

Bioaccumulation

Chemical Name Log Pow


Glycerin -1.76
56-81-5

Other adverse effects


No information available.

13. DISPOSAL CONSIDERATIONS


Waste treatment methods

Disposal methods This material, as supplied, is not a hazardous waste according to Federal regulations (40
CFR 261). This material could become a hazardous waste if it is mixed with or otherwise
comes in contact with a hazardous waste, if chemical additions are made to this material, or
if the material is processed or otherwise altered. Consult 40 CFR 261 to determine whether
the altered material is a hazardous waste. Consult the appropriate state, regional, or local
regulations for additional requirements.

Contaminated Packaging Dispose of contents/containers in accordance with local regulations.

California Hazardous Waste Codes 331

14. TRANSPORT INFORMATION

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DOT NOT REGULATED


Proper Shipping Name NON REGULATED
Hazard Class N/A

TDG Not regulated

MEX Not regulated

ICAO Not regulated

IATA Not regulated


Proper Shipping Name NON REGULATED
Hazard Class N/A

IMDG/IMO Not regulated


Hazard Class N/A

RID Not regulated

ADR Not regulated

ADN Not regulated

15. REGULATORY INFORMATION


International Inventories

TSCA Complies
DSL All components are listed either on the DSL or NDSL.

TSCA - United States Toxic Substances Control Act Section 8(b) Inventory
DSL/NDSL - Canadian Domestic Substances List/Non-Domestic Substances List

US Federal Regulations

SARA 313
Section 313 of Title III of the Superfund Amendments and Reauthorization Act of 1986 (SARA). This product does not contain any
chemicals which are subject to the reporting requirements of the Act and Title 40 of the Code of Federal Regulations, Part 372

SARA 311/312 Hazard Categories


Acute Health Hazard Yes
Chronic Health Hazard No
Fire Hazard No
Sudden release of pressure hazard No
Reactive Hazard No

CWA (Clean Water Act)


This product does not contain any substances regulated as pollutants pursuant to the Clean Water Act (40 CFR 122.21 and 40
CFR 122.42)

CERCLA
This material, as supplied, does not contain any substances regulated as hazardous substances under the Comprehensive
Environmental Response Compensation and Liability Act (CERCLA) (40 CFR 302) or the Superfund Amendments and
Reauthorization Act (SARA) (40 CFR 355). There may be specific reporting requirements at the local, regional, or state level
pertaining to releases of this material

US State Regulations

California Proposition 65

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This product does not contain any Proposition 65 chemicals.

U.S. State Right-to-Know Regulations

Chemical Name New Jersey Massachusetts Pennsylvania Rhode Island Illinois


Glycerin X X X X
56-81-5
Propylene Glycol X X
57-55-6
Titanium X
7440-32-6

International Regulations

Mexico
National occupational exposure limits
Component Carcinogen Status Exposure Limits
Glycerin - 10mg/m3 (mist) TWA
56-81-5 ( 3 - 7 )
Mexico - Occupational Exposure Limits - Carcinogens

Canada
WHMIS Hazard Class
Not determined

16. OTHER INFORMATION


NFPA Health Hazards 2 Flammability 0 Instability 0 Physical and
Chemical Hazards -
HMIS Health Hazards 3 Flammability 0 Physical Hazard 0 Personal Protection
X

Prepared By Product Stewardship


23 British American Blvd.
Latham, NY 12110
1-800-572-6501
Revision Date 24-Aug-2015
Revision Note No information available

Disclaimer
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at
the date of its publication. 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 in any process, unless specified in the text

End of Safety Data Sheet

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