Material Safety Data Sheet
1. PRODUCT IDENTIFICATION
2. COMPOSITION INFORMATION
Component Weight% CAS# OSHA PELACGIH TLV
Ciprofloxacin 0.2 85721-33-1 NONE NONE
Dextrose Monohydrate 5.0 5996-10-1 NONE NONE
Lactic Acid
Material Safety Data Sheet >94.0
7732-18-5
NONE
NONE.
3. HAZARD IDENTIFICATION
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
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EMERGENCY OVERVIEW: Material is clear to yellow liquid. Avoid
contact with eyes, skin and clothing. Do not taste or swallow. Wash thoroughly. after handling.
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Material Safety Data Sheet
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, induce 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
NOTES TO HEALTH PROFESSIONALS:See patient package insert in case pack/carton for complete information.
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Material Safety Data Sheet
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.
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Material Safety Data Sheet
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.
Precautions to be taken in handling and storing: Store between 5º to 25°C (41º
to 77°F). Protect from light, avoid excessive heat, protect from freezing.
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.
Storage Temperature:
Minimum: 5°C (41°F)
Maximum: 25°C (77°F)
Shelf Life: Do not use after expiration date.
Other Precautions: None identified.
8. CONTROL MEASURES AND PERSONAL PROTECTIVE
EQUIPMENT
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Release to Water: Refer to the local water authority; drain disposal is not recommended. Refer to local, state, and federal guidelines.
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Material Safety Data Sheet
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
Physical State: Liquid
Specific Gravity: Approx. to water
Appearance: A clear colorless to pale yellow solution
Melting Point/Range: Not applicable
Boiling Point/Range: Approximate to water
Evaporation Rate: Approx. to water
Vapor Pressure: Approximate to water
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Ahmedabad – 380006, Indiawww.clarislifesciences.com
Injectables Limited
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Material Safety Data Sheet
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.
Mutogenicity: 2 of the 8 invitro mutogenicity tests conducted with Ciprofloxacin
were positive, but 3 in vivo test systems gave negative results.
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Solubility in Water: Soluble
Vapor Density: Approximate to water
pH: 3.5-4.6
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Material Safety Data Sheet
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evidence of impaired fertility or harm to the fetus due to ciprofloxacin.
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
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Material Safety Data Sheet
For Ciprofloxacin: RTECS # VB1993800
LD50, oral, mouse = 5 mg/kg
LD50, subcutaneous, mouse ≥ 1 gm/kg
LD50, oral, rat ≥ 2 gm/kg
LD50, subcutaneous, rat ≥ 1 gm/kg
LD50, intravenous, mouse = 122 mg/kg
LD50, intraperitoneal, mouse = 1165 mg/kg
LD50, intravenous, rat = 207 mg/kg
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.
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Ahmedabad – 380006, Indiawww.clarislifesciences.com
Injectables Limited
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Material Safety Data Sheet
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)
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.
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Ahmedabad – 380006, Indiawww.clarislifesciences.com
Injectables Limited
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Material Safety Data Sheet
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.
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Claris Injectables Limited Corporate Headquarters, Ellisbridge
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Injectables Limited
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