SECTION 2: COMPOSITION/INFORM ATION ON INGREDI ENTS
Mixtures
Chemical Name Common Name and Synonyms CAS Number %
Bacitracin Zinc USP 1405-89-6 Proprietary
Neomycin Sulfate 1405-10-3 Proprietary
Polymixin B Sulfate 1405-20-5 Proprietary
Petrolatum 8009-03-8 Proprietary
SECTION 3: 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.
If swallowed, g et medical help or contact a Po i so n Con tr ol Center immediately.
Physical Hazards: This mixture does not meet the classification criteria according to O S HA Hazcom 2012.
Health Hazards: This mixture does not meet the classification criteria according to O S HA Hazcom 2012.
Environmental Hazards: This mixture does not meet the classification criteria according to O S HA Hazcom 2012.
OSHA Defined Hazards: This mixture does not meet the classification criteria according to OSHA Hazcom 2012.
Label Elements:
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.
Hazard Statement: The mixture does not meet the criteria for classification .
Precautionary Statement:
Prevention None required accordi n g to OS HA Hazcom 2012.
Response None required according to OS HA Hazcom 2012.
Storage None required according to OS HA 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.
Route of Entry:
Skin Contact: May cause irritation, redness, inflammation or dryness.
Skin Absorption: No adverse conditions expected.
Eye Contact: Direct contact wi th eyes may cause temporary irritation.
Inhalation: Not expected due to form.
Ingestion: May cause irritation of the digestive tract.
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SECTION 4: FIRST AID MEASURES
Skin Contact: Wash off with w arm water and soap. Get medical attention if symptoms occur.
Skin Absorption: No adverse conditions expected.
Eye Contact: Flush eyes with clear runn i n g water for a minimum o f 15 minutes; if irritatio n p ersists, 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 fi res th at 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 – Sensiti vity to Static Discharge: No unusual fire or explosion hazards noted.
Hazardous Combustion Products: Carbon oxides. Nitrogen Oxides (NOx).
Personal precautions,
Protective equipment and
Emergency procedures: Wear appro p riate personal protective equipment.
Methods and materials
for containment
and clean up: Absorb spill with vermiculite or o ther inert material, then place i n 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 thoro ug h ly to
remove residual contamination.
Environmental Precautions: Avoid discharge into drains and w ater so u rces.
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.
Biological Limit Values: No biological Exposure limits noted for the ingredients.
Ventilation and Engineering Controls: Ensure adequ ate ven ti lation.
Personal Protective Equi p m en t: 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 shoul d b e n ear by and ready to use.
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 informati o n avai lable.
Flash Point: N/A
Explosive Properties: No information available.
Oxidizing Properties: No information available.
Specific Gravity: 0.87
Water Solubility: Insoluble.
Partition Coefficien t: No information available.
Viscosity: No infor m ation available.
Vapor Pressure (mm Hg): No i nfo r m ation available.
Vapor Density (Air=1): No information available.
Evaporation Rate: No information availab le.
% Volatile: No infor mation 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.
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 occu p ati o n al setting is mild ir ritation of contaminated skin.
Accidental ingestion may be harmful. Although unlikely, irritation can i rr i tate th e resp iratory 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 lun gs. Symptoms are generally alleviated upon breathing fresh ai r .
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:
Petrolatum (CAS 8009-03-8)
• Oral: Not available.
• Dermal: 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: This product is not expected to cause reprod u ctive effects.
SECTION 12: 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 org an isms.
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 di sp o se i n sealed containers at licensed w aste disposal site.
Dispose in accordance with local, state and federal regulati o n s.
: The components of this product are not reported to cause mutagenic or embryonic effects in
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 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:
INTERNATIONAL REGULATIONS:
Warning: This product does contain a chemical known to the State of Cal i fo rn ia 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)
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 I n China (IECSC) No
Europe European List of Notified Chemical Substances (EINECS) Yes
Europe European List of Notified Chemical Substances (E LINCS) 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 Su b stances (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.
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 handlin g , use, processing, storage, tran sp o rtation, disposal and release an d 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 o r p ro cesses.