Note: Ingredients listed on restricted chemical lists
EC/CAS
9005-65-6
Name of the chemical
polyethyleneglycol sorbitan monooleate
Concentration
N/A
EC/CAS
9003-39-8
Name of the chemical
polyvinylpyrrolidone
Concentration
N/A
EC/CAS
7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
General Information
Revision date
2016-06-29
Product name
Otovel (Ciprofloxacin and Fluocinolone Acetonide) Otic Solution
Product Synonyms
Ciprofloxacin and Fluocinolone Acetonide Otic Solution
1.2.1 Relevant identified uses
Treatment of acute otitis media How Supplied: Blue translucent single-dose 0.25 mL vials
Emergency telephone
Assistance US
Icons in SDS
Company Information
company name
Arbor Pharmaceuticals, LLC
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302, H313, H361, H373
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
NFPA Rating Emergency Overview
Physical hazards
None 0 Minimal Hazard Reactivity: 0 Minimal Hazard
Health hazards
Acute toxicity, oral Category 4 Acute toxicity, dermal Category 1 Skin corrosion/irritation Category 2 Reproductive toxicity Category 2 Specific target organ toxicity, repeated exposure Category 1 (endocrine system) GHS-US Labeling 2 Moderate Hazard Flammability: 1 Slight Hazard 2 – Warning Fire: 1 – Combustible if heated 2 0 Reactivity Hazard: 0 – Stable
Hazard statements
H302: Harmful if swallowed H313: May be harmful in contact with skin H361: Suspected of damaging fertility or the unborn child H373: May cause damage to organs through prolonged or repeated exposure
Precautionary statements
P261 Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray. P264 Wash skin thoroughly after handling. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P304 + P340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P312 Call a POISON CENTER or doctor/ physician if you feel unwell. P332 + P313 If skin irritation occurs: Get medical advice/ attention. P337 + P313 If eye irritation persists: Get medical advice/ attention. P362 Take off contaminated clothing and wash before reuse. P403 + P233 Store in a well-ventilated place. Keep container tightly closed. P501 Dispose of contents/ container to an approved waste disposal plant.
2.3 Other hazards
Minimal risk expected when handled in packaged form.
NFPA Ratings
1
Potential health effects
Acute Ingestion: This material may be harmful if swallowed. Inhalation: Aerosol generation from this product may be irritating to respiratory tract. May cause hypersensitivity reactions in susceptible individuals. Skin Contact: Contact of this material with the skin may cause toxicity or irritation. May cause hypersensitivity reactions in susceptible individuals. Eye Contact: Contact of this material with the eye will cause irritation. Chronic Chronic exposure may cause possible hypersensitization. Prolonged inhalation may be harmful. May cause damage to organs through prolonged or repeated exposure. FOR MORE TOXICOLOGY INFORMATION REFER TO SECTION 11
