Cipro 1% vials msds claris inc.doc

Material Safety Data Sheet
CIPROFLOXACIN INJECTION, USP (1% w/v)

1. PRODUCT IDENTIFICATION

Common/Trade Name:
How Supplied:
Fill volume 20 mL in 20 mL glass vials Type I Fill volume 40 mL in 40 mL glass vials Type I Chemical Class:
3-Quinolinecarboxylic acid, 1,4-dihydro-1- Chemical Name:
cyclopropyl-6-fluoro-4-oxo-7- (1-piperazinyl)- Formula:
Product Type:
Product Use:
Distributor Name:
Distributor Address:
Manufacturer's Name:
Address:
Telephone Number For Information/
Medical Emergency
Date Prepared:
2. COMPOSITION INFORMATION
Component
Material Safety Data Sheet
CIPROFLOXACIN INJECTION, USP (1% w/v)
3. HAZARD IDENTIFICATION

EMERGENCY OVERVIEW: Material is clear to yellow liquid. Avoid contact with eyes,
skin and clothing. Do not taste or swallow. Wash thoroughly after handling.
Routes of Entry: Ciprofloxacin Injection may be absorbed via contact with skin or eyes; inhalation
of aerosols or accidentally ingested. Under normal use with supervision of a physician, Ciprofloxacin
Injection presents little hazard.

Health Hazard (Acute & Chronic): Ciprofloxacin is used as a gram-negative and gram-positive
antibiotic and may affect the digestive, central nervous system and kidneys. Minimal health hazard
is expected upon occupational exposure.
General Effects of Exposure:
Acute Effects of Exposure: Acute overexposure to this product may cause nausea, diarrhea,
vomiting, headache, rash, phototoxicity, and abdominal pain /discomfort. Due to the packaging of
this product worker exposure is not expected to occur, however, if accidental release of the product
does occur, contact with this product may cause slight eye and skin irritation based on the pH of this
product.
Chronic Effects of Exposure:
Chronic overexposure to this product may cause tremor, restlessness, and lightheadedness.

Carcinogenicity:
NTP? None
IARC Monographs? None
OSHA Regulated? None
Signs & Symptoms of Exposure: Acute signs and symptoms of exposure may include eye, skin,
and respiratory irritation. May cause nausea, vomiting, abdominal pain, headache, nervousness,
restlessness, or skin rash.

Medical Conditions Generally Aggravated by Exposure: Hypersensitivity to any component of
the preparation.
4. FIRST AID MEASURES
Eye Exposure: Flush eyes with large volumes of water for 15 minutes or more. Seek treatment
from a physician.
Skin Exposure: Wash skin with cool, soapy water. Remove contaminated clothing. Contact a
physician if irritation develops.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately. If
person in conscious induces vomiting; never induce vomiting on in unconscious person. Contact
poison control center.

Inhalation: If difficulty breathing, administer oxygen. Seek medical attention immediately. If
necessary, provide artificial respiration. Overdose should be treated symptomatically.
Material Safety Data Sheet
CIPROFLOXACIN INJECTION, USP (1% w/v)

NOTES TO HEALTH PROFESSIONALS:
See patient package insert in case pack/carton for complete information.

5. FIRE AND EXPLOSION HAZARD DATA

Flash Point (Method Used): Not applicable
Lower Explosion Limit: Not Established (LEL%)
Upper Explosion Limit: Not Established (UEL %)
Flammable Limits: Not applicable
Extinguishing Media: Use water or multi-purpose ABC extinguisher
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire
fighters must wear self-contained breathing apparatus to avoid inhalation of smoke. Product is not
expected to present a fire hazard concern.
Unusual Fire/Explosion Hazards: None known
6. ACCIDENTAL RELEASE INFORMATION

Release to Land: Absorb Ciprofloxacin with absorbent materials and dispose according to local,
state, and federal guidelines. Prevent contact with sewers and waterways. Wash area with soap
and water. Wear personal protective equipment.
Release to Air: If aerosolized, reduce exposures by ventilating area; clean up spill immediately to
prevent evaporation. Wear respiratory protection as necessary.
Release to Water: Refer to the local water authority; drain disposal is not recommended. Refer to
local, state, and federal guidelines.

7. PRECAUTION FOR SAFE HANDLING AND USE
Steps to be taken in case material is released or spilled: See Section 6 above. Wear all
necessary protective equipment including nitrile or latex gloves, protective clothing, safety glasses.
A dust/mist respirator (N95) may be necessary if excessive aerosols are generated. Large spills
may require the use of protective coveralls, boots, double gloves and SCBAs.
Waste Disposal Method: Dispose of according to local, state, and federal guidelines. Incineration
at a licensed facility is recommended.
Storage Temperature:
Store between 5º to 30°C (41º to 86°F). Protect from light, avoid excessive heat, protect from
freezing.
Precautions to be taken in handling and storing:
Keep this and all drugs out of the reach of children. Store in a dry place away from excessive hear.
Containers should be kept tightly closed to prevent contamination .Use normal precaution for
storage of a drug. Avoid contact with eyes. Avoid contact with skin or clothing. Wash thoroughly
after handling.
Shelf Life: Do not use after expiration date.
Other Precautions: None identified.
Material Safety Data Sheet
CIPROFLOXACIN INJECTION, USP (1% w/v)
8. CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT

Respiratory Protection: Under normal use, respirators should not be required if adequate
ventilation is available. A dust/mist respirator (N95) may be necessary if excessive aerosols are
generated.
For large spill emergencies, self-contained breathing apparatus (SCBA) may be required.
Personnel wearing respirators should be fit tested and approved for respirator use under the
OSHA Respiratory Protection Standard, 29 CFR 1910.134.
Ventilation: Handle product in a well-ventilated area.
Protective Gloves: Nitrile or latex
Eye Protection: Safety glasses or goggles
Other Protective Clothing or Equipment: Lab coat
Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking when
handling this product.
9. PHYSICAL AND CHEMICAL PROPERTIES

A clear colorless to pale yellow solution
10. STABILITY AND REACTIVITY DATA

Stability: Stable
Incompatibility (Materials to Avoid): Oxidizing agents. See product insert and the physicians’
Desk Reference (PDR) for Drug Interaction. Hazardous Decomposition or Byproducts: Decomposition products of this compound may
include potentially hazardous byproducts of nitrogen oxides, carbon monoxide, carbon dioxide, and hydrogen fluoride. Hazardous Polymerization: Will not occur.
Conditions to Avoid: None identified
11. TOXICOLOGICAL INFORMATION

Carcinogenicity: After daily dosing to mice and rats for upto 2 years, there is no evidence that
Ciprofloxacin has any carcinogenic or tumorigenic effects in these species.
Material Safety Data Sheet
CIPROFLOXACIN INJECTION, USP (1% w/v)

Mutagenicity: 2 of the 8 invitro mutagenicity tests conducted with Ciprofloxacin were positive, but
3 in vivo test systems gave negative results.
Reproductive Toxicity: Reproduction studies have been performed in rats and mice at doses
upto 6 times the usual daily human dose and have revealed no evidence of impaired fertility or
harm to the fetus due to ciprofloxacin.
For Ciprofloxacin: RTECS # VB1993800

12. ENVIRONMENTAL IMPACT INFORMATION
Information is currently not available on the environmental impact of Ciprofloxacin. Handle in a manner that prevents spills or releases to the environment. 13. DISPOSAL INFORMATION
Ciprofloxacin should be disposed of in accordance with national, state, local, or applicable regulations. Incineration at an approved, permitted facility is recommended.
14. TRANSPORTATION INFORMATION
Ciprofloxacin is not a DOT Hazardous Material. Ciprofloxacin is not a Marine Pollutant.
15. REGULATORY INFORMATION
United States Federal Regulations
OSHA Hazcom Standard Rating: Non-Hazardous
TSCA Inventory List: This product is exempt from TSCA Regulation under Section 3(2)(B)(vi)
when used for pharmaceutical application.
CERCLA Hazardous Substance: None
SARA Title III
SARA Section 302 Extremely Hazardous Substances: Exempt
SARA Section 311/312 Hazard Categories: Exempt from SARA Section 311/312
SARA Section 313 Toxic Chemicals: Exempt

RCRA Status: If discarded in its purchased form, this product would not be a hazardous waste
either by listing or by characteristic. However, under RCRA, it is the responsibility of the product
user to determine at the time of disposal, whether a material containing the product or derived from
the product should be classified as a hazardous waste. (40 CFR 261.20-24)
Material Safety Data Sheet
CIPROFLOXACIN INJECTION, USP (1% w/v)
The following chemicals are specifically listed by individual states; other product specific health and safety data in other sections of the MSDS may also be applicable for state requirements. For details on your regulatory requirements you should contact the appropriate agency in your state.
16. OTHER DATA

The information in this document is believed to be correct as of the date issued. HOWEVER, NO
WARRANTY OF MERCHANTABILITY, FITNESS FOR ANY PARTICULAR PURPOSE, OR ANY
OTHER WARRANTY IS EXPRESSED OR IS TO BE IMPLIED REGARDING THE ACCURACY
OR COMPLETENESS OF THIS INFORMATION, THE RESULTS TO BE OBTAINED FROM THE
USE OF THIS INFORMATION OR THE PRODUCT, THE SAFETY OF THIS PRODUCT, OR THE
HAZARDS RELATED TO ITS USE. This information and product are furnished on the condition
that the person receiving them shall make his own determination as to the suitability of the product
for his particular purpose and on the condition that he assumes the risk of his use thereof.

Source: http://www.clarislifesciences.com/claris_usa/Product/MSDS/Cipro%20Vials%20MSDS%20Claris%20Inc.pdf