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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR524.1982]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 524.1982 Proparacaine ophthalmic solution.

(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.

[40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, 2014]

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