Johnson & Johnson 8295 User Manual

US - OSHA SAFETY DATA SHEET

Issue Date: 5/11/15

Revision Date Version 1

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1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDER T AKING

Product identifier

Product Name

Motrin caplets

Other means of identification

Product Code

C-843

Synonyms

Motrin IB Caplet

Recommended use of the chemical and restrictions on use

Recommended Use

Temporarily relieves minor aches and pains due to: headaches, muscular aches, minor pain of arthritis, toothache, backache, the common cold, menstrual cramps. Temporarily reduces fever.

Uses advised against

None Known.

Details of the supplier of the safety data sheet

Supplier Address

McNeil Consumer Healthcare, Division of McNeil

-PPC, Inc.

7050 Camp Hill Rd. Fort Washington, PA 10934

Emergency telephone number

Company Phone Number

(215) 273-7000

24 Hour Emergency Phone Number

For 24-hour emergency assistance, call the 3E Company at 1 (877)-236-9871 Provide the technician with the following product tracking code: 2277

2. HAZARDS IDENTIFICATION

Classification

Health Hazards

Not classified.

Physical hazards

Not Classified.

OSHA Regulatory Status

Over the counter drugs in their so lid fi nal form (e.g. capsule s, tab lets or pills) are co ns idered exempt under th e criteria of the Federal OSHA Hazard Communication Standard 29 CFR 1910.1200. However, in an industrial setting where a component's occupation exposure limits may be surpassed, they can be considered hazardous.

-2299

al

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Label elements

Emergency Overview

Hazard statements

This material does not meet the criteria for classification.

Hazard Symbol

None

Signal word

None

Appearance Orange film coated cap let printed with "Motrin IB" in black ink

Physical state Solid

Odor Not available.

Precautionary Statements - Prevention

Not available.

Precautionary Statements - Response

No specific first aid measures noted.

Precautionary Statements - Storage

Store at 20 -25 °C (68 - 77 °F) in a dry place.

Precautionary Statements - Disposal

Dispose of contents/container in accordance with local/regional/national/international regulations.

Hazards not otherwise classified (HNOC)

Not classified.

Other Information

3. COMPOSITION/INFORMATION ON INGREDIENTS

Synonyms

Motrin IB Caplet

Chemical Name

CAS No.

Weight-%

Ibuprofen USP

15687-27-1

60-70

Corn starch

9005-25-8

10-30

Pregelatinized starch NF

9005-25-8

1-5

4. FIRST AID MEASURES

First aid measures

Eye contact

In case of eye contact, immediately flush eyes with fresh water for at least 15 minutes while holding the eyelids open. Remove contact lenses if worn. Get medical attention if irritation persists.

Skin Contact

Should skin irritation, allergic reaction, or rash occur, remove contaminated clothing if required, then physically remove as much of the product as possible. Wash affected area with soap and water, then thoroughly flush the area with water. If irritation medical advice.

Inhalation

If symptomatic, move to fresh air. Get medical attention if symptoms persist.

Ingestion

If symptomatic, seek medi cal a dv ice. If i nge sti on of a large amount does oc cur, cal l a po iso n control center immediately.

Most important symptoms and effects, both acute and delayed

Symptoms

No information available.

persists, seek

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Indication of any immediate medical attention and special treatment needed

Note to physicians

Treat symptomatically.

5. FIRE-FIGHTING MEASURES

Suitable extinguishing media

Extinguish with water spray, carbon dioxide, dry chemical or material appropriate for the surrounding fire.

Unsuitable extinguishing media

None known.

Specific hazards arising from the chemical

Not applicable.

Explosion data

Sensitivity to Mechanical Impact

None known.

Sensitivity to Static Discharge

None known.

Protective equipment and precautions for firefighters

Wear sel f-contained breathing apparatus and protective clothing.

6. ACCIDENTAL RELEASE MEASURES

Personal precautions, protective equipment and emergency procedures

Personal precautions

Wear appropriate personal protective equipment (see Section 8).

Environmental precautions

See Section 12 for additional ecological information.

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

Vacuum and place into proper container for disposal.

7. HANDLING AND STORAGE

Precautions for safe handling

Advice on safe handling

Observe good industrial hygiene practices. Minimize dust generation and accumulation.

Conditions for safe storage, including any incompatibilities

Storage Conditions

Keep only in the original container. Store at 20 - 25 °C (68 - 77 °F). Keep away from food, drink, and animal feedingstuffs. Keep out of reach of children.

Incompatible materials

None known based on information supplied. Strong oxidizing agents

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Control parameters

Biological limit values

No biological limits noted for this ingredient(s).

Exposure Guidelines

Based on a review of animal and clinical literature, an Occupational Exposure Limit (OEL) of

1100 μg/m

3

is recommended as an 8-hour TWA for Ibuprofen.

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Chemical Name

ACGIH T LV

OSHA PEL

NIOSH

Corn starch

9005-25-8

TWA: 10 mg/m3

TWA: 15 mg/m3 total dust

TWA: 5 mg/m3 respirable fraction

TWA: 10 mg/m3 total dust

TWA: 5 mg/m3 respirable dust

Pregelatinized Starch NF

9005-25-8

TWA: 10 mg/m3

TWA: 15 mg/m3 total dust

TWA: 5 mg/m3 respirable fraction

TWA: 10 mg/m3 total dust

TWA: 5 mg/m3 respirable dust

Appropriate engineering controls

Engineering Controls

The health hazard risks of handling this material are dependent on factors, such as physical form and quantity. Site

-specific risk assessments should be conducted to determine the

appropriate exposure contr ol measures. Good ge neral ventilat ion should be use d. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If ex posure li mits h ave not be en esta blishe d, maintain airb orne levels as low as reasonably achievable.

Individual protection measures, such as personal protective equipment

Eye/face protection

None required for consumer use. In laboratory, medical or industrial settings, safety glasses wi required depending on the industrial exposure setting. Contact a health and safety professional for specific inform ation .

Skin and body protection

None required for consumer use. In laboratory, medical or industrial settings, gloves and lab coats are recommended. The use of additional personal protective equipment such as shoe coverings, gauntlets, and hood or head covering s may be neces sary . Cont act safety professional for specific information.

Respiratory protection

None required for consumer use. Respirators may be required for certain laboratory and manufacturing tasks if engineering controls do not maintain airborne concentrat recommended exposure limits (where applicable) or to an acceptable level (where the exposure limits have not been establishe d). Workplace risk assessments should be completed before specif ying and impleme nting respirator usage. All res pirators mu st conform to specifications for e fficiency a nd performance. In the United States of Ameri ca, if resp irators are used, a progra m sho uld be in stit uted t o a ssur e co mpli an c e with OSHA Standard 2 9 CFR

1910.134. Contact a health and safety professional or manufactur er for spe cif ic infor mat ion .

General Hygiene Considerations

Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants.

9. PHYSICAL AND CHEMICAL PROPERTIES

Information on basic physical and chemical properties

Physical state

Solid

Appearance

Orange film coated caplet printed with "Motrin IB" in black ink

Odor

Not available.

Color

Orange

Odor threshold

Not available.

Property

Values

Remarks • Method

pH

Not available.

Melting point/freezing point

Not available.

Boiling point / boiling range

Not available.

Flash point

Not available.

Evaporation rate

Not available.

Flammability (solid, gas)

Not available.

Flammability Limit in Air

Upper flammability limit:

Not available.

Lower flammability limit:

Not available.

Vapor pressure

Not available.

Vapor density

Not available.

Specific Gravity

Not available.

Water solubility

Not available.

th side shields are recommended. The use of goggles or full face protection may be

a health and

ions below

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Solubility in other solvents

Not available.

Partition coefficient

Not available.

Autoignition temperature

Not available.

Decomposition temperature

Not available.

Kinematic viscosity

Not available.

Dynamic viscosity

Not available.

Explosive properties

Not available.

Lower explosive limit:

Not available.

Upper explosive limit:

Not available.

Oxidizing properties

Not available.

10. STABILITY AND REACTIVITY

Reactivity

Stable at normal conditions.

Chemical stability

Stable.

Possibility of Hazardous Reactions

Hazardous polymerization does not occur.

Conditions to avoid

Low and elevated temperatures. Minimize dust generation and accumulation.

Incompatible materials

None known based on information supplied. Strong oxidizing agents.

Hazardous Decomposition Products

Carbon oxides. Silicon oxides. Nitrogen oxides. Sodium oxides.

11. TOXICOLOGICAL INFORMATION

Information on likely routes of exposure

Product Information

No data available.

Inhalation

Under normal conditions of intended use, this material is not expected to be an inhalation hazard.

Eye contact

Product dust or powder may cause mechanical eye irritation.

Skin Contact

This product is not expected to be a skin hazard.

Ingestion

Expected to be a low ingestion hazard.

Acute toxicity

Ingestion of ibuprofen of less than 200 mg/kg rarely cause significant toxicity. Ingestion of ibuprofen of greater than 400 mg/kg may result in serious effects.

Chemical Name

Oral LD50

Dermal LD50

Inhalation LC50

Intravenous LD50

Ibuprofen USP 15687-27-1

= 636 mg/kg ( Rat )

-

Information on toxicological effects

Symptoms

Symptoms associated with ibuprofen include the mild GI upset (ie, nausea, vomiting and abdominal pain). The adverse effe acute renal failure, fluid retention, interstitial nepritis and nephritic syndrome.

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

Skin corrosion/irritation

Not available.

Serious eye damage/eye irritation

Not available.

cts are dyspepsia, ulceration, perforation, hemorrhage,

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Irritation

Not available.

Corrosivity

Not available.

Sensitization

This product is not expected to cause skin sensitizat ion.

Germ cell mutagenicity

This product is not expected to cause mutagenic or genotoxic effects.

Carcinogenicity

Not available.

Reproductive toxicity

Not available.

Developmental Toxicity

Not available.

Teratogenicity

Not available.

STOT - single exposure

Not classified.

STOT - repeated exposure

Not classified.

Chronic toxicity

Not available.

Subchronic toxicity

Not available.

Target Organ Effects

Not available.

Neurological effects

Not available.

Other adverse effects

Not available.

Aspiration hazard

Due to the physical form of the product it is not an aspiration hazard.

Numerical measures of toxicity - Not available.

12. ECOLOGICAL INFORMATION

Ecotoxicity

This product's component s are not c lassif ied as enviro nmenta lly haz ardous. H owev er, thi s does n ot ex clude the possi bility that large or frequent spills can have a harmful or damaging effect on the environment.

Persistence and degradability

No information available.

Bioaccumulation

No information available.

Mobility

No information available.

Other adverse effects

No information available.

13. DISPOSAL CONSIDERATIONS

Waste treatment methods

Disposal of wastes

Dispose in accordance with applicable federal, state, and local regulations.

Local disposal regulation

Dispose in accordance with local regulations.

Hazardous waste code

Hazardous waste codes should be determined in accordance with hazardous waste regulatory authorities.

Waste from residue / unused packaging

Dispose in accordance with applicable regulations.

Contaminated packaging

Since emptied containers may retain product residue, follow label warnings even after container is emptied.

14. TRANSPORT INFORMATION

DOT

Not regulated as a hazardous material by DOT.

IATA

Not regulated as a dangerous good.

IMDG

Not regulated as a dangerous good.

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Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

This substance/mixture is not intended to be transported in bulk.

15. REGULATORY INFORMATION

International Inventories

TSCA

Complies

DSL/NDSL

Complies

EINECS/ELINCS

Complies

ENCS

Complies

IECSC

Does not comply

KECL

Complies

PICCS

Complies

AICS

Complies

Legend:

TSCA - United States Toxic Substances Control Act Section 8(b) Inventory

DSL/NDSL - Canadian Domestic Substances List/Non-Domestic Substances List

EINECS/ELINCS - European Inventory of Existing Chemical Substances/European List of Notified Chemical Substances

ENCS - Japan Existing and New Chemical Substances

IECSC - China Inventory of Existing Chemical Substances

KECL - Korean Existing and Evaluated Chemical Substances

PICCS - Philippines Inventory of Chemicals and Chemical Substances

AICS - Australian Inventory of Chemic al Subst ances

US Federal Regulations

US OSHA Specifically Regulated Substances (29 CFR 1910.1001

-1050)

Over Hazard Communication S ta

However, in an indus trial setting w here a compone nt’s occupationa l exposur e

limits may be surpassed, t

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

No

Chronic Health Hazard

No

Fire hazard

No

Sudden release of pressure hazard

No

Reactive Hazard

No

Drug Enforcement Administration (DEA) List 1 & 2 Exempt Chemical Mixtures (21 CFR 1310.12(c))

Not regulated

DEA Exemp

Not regulated

Clean Air Act (CAA) Section 112 Hazardous Air Pollutants (HAPS) List

Not regulated

Clean Air Act (CAA) Section 112(r) Accidental Release Prevention (40 CFR 68.130)

Not regulated

CWA (Clean Water Act)

This product does not co ntai n any sub stan ce s reg ulated as pollutants pur sua nt to t he Cl ean Water Act (40 CFR 122. 21 a nd 40 CFR

122.42).

Safe Drinking Water Act (SDWA)

Not regulated

CERCLA

-the-counter drugs in their solid final form (e.g. tablets or pills) are considered exempt under the criteria of the Federal OSHA ndard 29 CFR 1910.1200.

hey can be considered hazardous listed.

t Chemical Mixtures Code Number

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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

This product does not contain any Proposition 65 chemicals.

U.S. State Right-to-Know Regulations

This product may contain substances regulated by state right-to-know regulations.

Chemical Name

New Jersey

Massachusetts

Pennsylvania

Corn starch

9005-25-8

-

X

Pregelatinized star ch NF

9005-25-8

-

X

U.S. EPA Label Information

EPA Pesticide Registration Number

Not available.

16. OTHER INF OR MATION

Issue Date: 5/11/15

Revision Note

Not 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 guidance for safe handling, use, processing, storage, transportation, disposal and rel ease and is not t o be c ons idered a warr anty or quality specifi catio n. Th e inf ormatio n relat e s 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