Skip to main content
Find a Lawyer

Code of Federal Regulations Title 21. Food and Drugs § 21.524.1982 Proparacaine ophthalmic solution

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Specifications. The drug is an aqueous solution containing 0.5 percent proparacaine hydrochloride, 2.45 percent glycerin as a stabilizer, and 0.2 percent chlorobutanol (choral derivative) and 1:10,000 benzalkonium chloride as preservatives.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—

(1) Amount. It is administered as follows:

(i) For removal of sutures:  Instill one to two drops 2 or 3 minutes before removal of stitches.

(ii) For removal of foreign bodies from eye, ear, and nose:  For ophthalmic use, instill three to five drops in the eye prior to examination;  for otic use, instill five to ten drops in the ear;  for nasal use, instill five to ten drops in each nostril every 3 minutes for three doses.

(iii) For tonometry:  Instill one to two drops immediately before measurement.

(iv) As an aid in treatment of otitis:  Instill two drops into the ear every 5 minutes for three doses.

(v) For minor surgery:  Instill one or more drops as required.

(vi) For catheterization:  Instill two to three drops with a blunt 20–gauge needle immediately before inserting catheter.

(2) Indications for use. For use as a topical ophthalmic anesthetic. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected;  as an aid in the removal of foreign bodies from the nose and ear canal;  as an accessory in the examination and treatment of painful otitis, in minor surgery, and prior to catheterization.

(3) Limitations. Keep away from eyes or other mucous membranes;  avoid inhaling;  use with adequate ventilation;  in case of deep or puncture wounds or serious burns, consult a veterinarian.

(d) Conditions of use.

(1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected. Local applications may also be used as an aid in the removal of foreign bodies from the nose and ear canal, as an accessory in the examination and treatment of painful otitis, in minor surgery, and prior to catheterization.

(2) It is administered as follows:

(i) For removal of sutures:  Instill one to two drops 2 or 3 minutes before removal of stitches.

(ii) For removal of foreign bodies from eye, ear, and nose:  For ophthalmic use, instill three to five drops in the eye prior to examination;  for otic use, instill five to 10 drops in the ear;  for nasal use, instill five to 10 drops in each nostril every 3 minutes for three doses.

(iii) For tonometry:  Instill one to two drops immediately before measurement.

(iv) As an aid in treatment of otitis:  Instill two drops into the ear every 5 minutes for three doses.

(v) For minor surgery:  Instill one or more drops as required.

(vi) For catheterization:  Instill two to three drops with a blunt 20–gauge needle immediately before inserting catheter.

(3) For use only by or on the order of a licensed veterinarian.

Previous Part of Code Next Part of Code
Back to Chapter List

Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.524.1982 Proparacaine ophthalmic solution - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-524-1982/

FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.

Was this helpful?

Welcome to FindLaw's Cases & Codes

A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.

Go to Learn About the Law

Latest Blog Posts

For Legal Professionals

Learn About The Law

Get help with your legal needs

FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)

Copied to clipboard