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Ophthaine® Solution Rx 009-035
Manufacturer:  Zoetis, Inc. Approved
    Therapeutic Drug
Formulation: An aqueous solution containing 0.5% proparacaine HCl, 2.45 percent glycerin (as a stabilizer)  
Warning: The long term toxicity of proparacaine is unknown. Prolonged use may delay wound healing.
Approved in: Chicken, all use classes; Turkeys, all use classes; Calves, all use classes; Cattle, beef, all use classes; Cattle, dairy, all use classes; Horses; Cats; Dogs; Goats, all use classes; Sheep, all use classes; Swine, all use classes
Ingredient(s): proparacaine hydrochloride
Drug Class: Anesthetics, topical ophthalmic
Dose Form: Solution
Chicken, all use classes
Meat Withdrawal: Zero
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Turkeys, all use classes
Meat Withdrawal: Zero
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Calves, all use classes
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Cattle, beef, all use classes
Meat Withdrawal: Zero
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Cattle, dairy, all use classes
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Horses
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: 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 for the nose and ear canal, as an accessory in examination and treatment of painful otitis in minor surgery, and prior to catheterization.
Directions:
Administer as follows:
- For removal of sutures:  Instill 1 to 2 drops 2 or 3 minutes before removal of stitches.
- For removal of foreign bodies for eye, ear, and nose:  
   ophthalmic - instill 3 to 5 drops in the eye prior to examination;
   otic - instill 5 to 10 drops in the ear;
   nasal - instill 5 to 10 drops in each nostril every 3 minutes for 3 drops.
- For tonometry:  Instill 1 to 2 drops immediately before measurement.
- As an aid in treatment in otitis:  Instill 1 to 2 drops into each ear every 5 minutes for 3 dosages.
- For minor surgery:  Instill 1 or more drops as required.
- For catheterization:  Instill 2 to 3 drops with a blunt 20-gauge needle immediately before inserting catheter.
Further Info: Do not use in horses intended for human consumption.
Cats
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Dogs
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Goats, all use classes
Meat Withdrawal: Zero
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Sheep, all use classes
Meat Withdrawal: Zero
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.
Swine, all use classes
Meat Withdrawal: Zero
Route(s): Auricular (Otic); Nasal; Ophthalmic; Topical
Indications: Use for the induction of surface anesthesia in ophthalmology. 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.
Directions:
Administer as follows--
- For suture removal, instill 1 drop to 2 drops 2 minutes or 3 minutes before the removal of stitches.
- For the removal of foreign bodies from the eye, instill 3 drops to 5 drops in the eye prior to examination.
- For the removal of foreign bodies from the ear, instill 5 drops to 10 drops in the affected ear.
- For the removal of foreign bodies from the nose, instill 5 drops to 10 drops in each nostril every 3 minutes for 3 doses.
- For tonometry, instill 1 drop to 2 drops immediately before measurement is made.
- For use as an aid in the treatment of otitis, instill 2 drops into the ear every 5 minutes for 3 doses.
- For minor surgery, instill 1 drop or more drops, as required.
- For catheterization, instill 2 drops to 3 drops with a blunt 20-gauge needle immediately before inserting the catheter.

Last FDA Update: FR 02/27/14
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