Note: Ingredients listed on restricted chemical lists
EC/CAS
77-92-9
Name of the chemical
Citric acid
Concentration
N/A
EC/CAS
8004-92-0
Name of the chemical
1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CI 47005) (35), (36)
Concentration
N/A
EC/CAS
2353-45-9
Name of the chemical
2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) when used as a substance in hair dye products
Concentration
N/A
EC/CAS
7732-18-5
Name of the chemical
Water, distilled, conductivity or of similar purity H2O
Concentration
N/A
EC/CAS
532-32-1
Name of the chemical
Benzoic acid and its sodium salt
Concentration
N/A
General Information
Revision date
2021-04-27
Product name
GOPRELTO , COCAINE HYDROCHLORIDE Nasal Solution
1.2.1 Relevant identified uses
GOPRELTO® and COCAINE HYDROCHLORIDE Nasal Solution (NS) are indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries of the oral, laryngeal and nasal cavities in adults
1.2.2. Uses advised against
GOPRELTO® and COCAINE HYDROCHLORIDE NS contain Cocaine
Manufacturer Name
Genus Lifesciences, Inc
Icons in SDS
Company Information
company name
Genus Lifesciences, Inc
GHS Information
Signal word
Warning
Section 2
2.1 Classification of the substance or mixture
The products GOPRELTO® and COCAINE HYDROCHLORIDE NS are a non-hazardous pharmaceutical mixture and do not meet OSHA’s Hazard Communication Standard (HCS) 2012, 29CFR 1910.1200 and OSHA’s Globally Harmonized System (GHS) hazard criteria. As per OSHA section 1910.1200(b)(6)(vii), “Any drug, as that term is defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), when it is in solid, final form for direct administration to the patient; drugs which are packaged by the chemical manufacturer for sale to consumers in a retail establishment” are exempt.. The GHS hazards listed below are for the product active ingredient, Cocaine HCl, and not for the Nasal Solution product itself.
Physical hazards
Not classified
Health hazards
Acute Oral Toxicity Category 3 Cardiovascular System and Central Nervous System category 1
Environmental hazards
Not classified
Signal word
Warning
Hazard statements
GOPRELTO® and COCAINE HYDROCHLORIDE NS active ingredient, Cocaine HCl, is a stimulant and a narcotic. The products have a high potential for abuse and dependence. It may be harmful. Accidental ingestion of large amounts may be fatal.
Precautionary statements
Generally safe at recommended doses. Avoid use in patients with a recent or active history of uncontrolled hypertension, unstable angina, myocardial infarction, coronary artery disease, or congestive heart failure. Avoid use of additional vasoconstrictor agents such as epinephrine or phenylephrine. Seek medical attention in case of accidental exposure or overdose. Resuscitative equipment should be immediately available when local anesthetic is used.
2.3 Other hazards
Common effects may include headache and epistaxis.
