Alcaine™

NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

ALCAINE™ ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. ALCAINE™ ophthalmic solution is not intended for patient self-administration.

Animal reproduction studies have not been conducted with ALCAINE^™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.

ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula:

Established Name: Proparacaine Hydrochloride

Chemical Name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride.

Molecular Weight: 330.85 g/mol

Each mL contains of ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5%:

Active: proparacaine hydrochloride 5 mg 0.5%. Preservative: benzalkonium chloride (0.01%).

Inactives: glycerin and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide.

ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in DROP-TAINER® dispensers as follows:

15 mL                NDC 0998-0016-15

Storage:

Bottle must be stored in unit carton to protect contents from light.

Store bottles under refrigeration at 2°C to 8°C (36°F to 46°F).

After opening, ALCAINE™ can be used until the expiration date on the bottle.

NOTE: ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution.

Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134

Revised: 06/2024





Alcon

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134 USA



© 2024 Alcon Inc.

Printed in USA

[email protected]

1-800-757-9195  





300063110-0723

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when proparacaine hydrochloride is administered to a nursing woman.

Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. Corneal edema has been reported following the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported.

Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported.

ALCAINE™ ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

ALCAINE™ ophthalmic solution is a rapidly-acting topical anesthetic, with induced anesthesia lasting approximately 10-20 minutes.

ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.

NDC 0998-0016-15



Alcon



Alcaine^™

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



15 mL   Sterile



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



Bottles must be stored in unit carton to protect from light.



STORAGE: Store between 2º to 8ºC (36º to 46ºF). After opening, ALCAINE™ can be used until the expiration date on the bottle.



ALCAINE^™ (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.



INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). Preservative: benzalkonium chloride 0.01%. Inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water



pH range 4.0 to 6.0



1-800-757-9195

[email protected]

Country of Origin: Switzerland



Alcon

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA     

Printed in USA

300056033-0922

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



15 mL   Sterile



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



Bottles must be stored in unit carton to protect from light.



STORAGE: Store between 2º-8ºC (36º-46ºF).



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.



INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). Preservative: benzalkonium chloride 0.01%. Inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water



pH range 4.0 to 6.0



1-800-757-9195

[email protected]

Country of Origin: Switzerland



Alcon

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA 

Printed in USA

300048624-0721

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



15 mL   Sterile



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



Bottles must be stored in unit carton to protect from light.



STORAGE: Store between 2º-8ºC (36º-46ºF).



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.



INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). Preservative: benzalkonium chloride 0.01%. Inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water



pH range 4.0 to 6.0



1-800-757-9195

[email protected]

Country of Origin: Switzerland



Alcon

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA 

Printed in USA

9016948-0119



SN:



LOT:



EXP:



GTIN:  00309980016156

NDC 0998-0016-15



Alcon



Alcaine^™

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



Sterile 15 mL



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



STORAGE: Store between 2º to 8ºC (36º to 46ºF).

After opening, ALCAINE^™ can be used until the expiration date on the bottle.



Bottles must be stored in unit carton to protect from light.



ALCAINE^™ (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.





INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%).





ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA     Printed in USA



LOT/EXP.:

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



Sterile 15 mL



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



STORAGE: Store between 2º-8ºC (36º-46ºF).



Bottles must be stored in unit carton to protect from light.



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.





INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%).





ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA     Printed in USA





LOT/EXP.:

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



Sterile 15 mL



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



STORAGE: Store between 2º-8ºC (36º-46ºF).



Bottles must be stored in unit carton to protect from light.



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.





INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%).





ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA     Printed in USA

A Novartis Division





LOT/EXP.:



H15466-1118

Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating.

Short Corneal and Conjunctival Procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses.

NOTE: ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution.

Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females.

NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.

ALCAINE™ ophthalmic solution is indicated for administration under the direct supervision of a healthcare provider. ALCAINE™ ophthalmic solution is not intended for patient self-administration.

Animal reproduction studies have not been conducted with ALCAINE^™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5%. It is also not known whether proparacaine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine hydrochloride should be administered to a pregnant woman only if clearly needed.

ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is a topical local anesthetic for ophthalmic use. The active ingredient is represented by the structural formula:

Established Name: Proparacaine Hydrochloride

Chemical Name: Benzoic acid, 3-amino-4-propoxy-,2-(diethylamino) ethyl ester, monohydrochloride.

Molecular Weight: 330.85 g/mol

Each mL contains of ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5%:

Active: proparacaine hydrochloride 5 mg 0.5%. Preservative: benzalkonium chloride (0.01%).

Inactives: glycerin and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide.

ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% is supplied in DROP-TAINER® dispensers as follows:

15 mL                NDC 0998-0016-15

Storage:

Bottle must be stored in unit carton to protect contents from light.

Store bottles under refrigeration at 2°C to 8°C (36°F to 46°F).

After opening, ALCAINE™ can be used until the expiration date on the bottle.

NOTE: ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution.

Distributed by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134

Revised: 06/2024





Alcon

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134 USA



© 2024 Alcon Inc.

Printed in USA

[email protected]

1-800-757-9195  





300063110-0723

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children over the age of twelve, and safety information in neonates and other pediatric patients.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when proparacaine hydrochloride is administered to a nursing woman.

Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. Corneal edema has been reported following the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported.

Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported.

ALCAINE™ ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

ALCAINE™ ophthalmic solution is a rapidly-acting topical anesthetic, with induced anesthesia lasting approximately 10-20 minutes.

ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.

NDC 0998-0016-15



Alcon



Alcaine^™

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



15 mL   Sterile



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



Bottles must be stored in unit carton to protect from light.



STORAGE: Store between 2º to 8ºC (36º to 46ºF). After opening, ALCAINE™ can be used until the expiration date on the bottle.



ALCAINE^™ (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.



INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). Preservative: benzalkonium chloride 0.01%. Inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water



pH range 4.0 to 6.0



1-800-757-9195

[email protected]

Country of Origin: Switzerland



Alcon

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA     

Printed in USA

300056033-0922

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



15 mL   Sterile



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



Bottles must be stored in unit carton to protect from light.



STORAGE: Store between 2º-8ºC (36º-46ºF).



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.



INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). Preservative: benzalkonium chloride 0.01%. Inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water



pH range 4.0 to 6.0



1-800-757-9195

[email protected]

Country of Origin: Switzerland



Alcon

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA 

Printed in USA

300048624-0721

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



15 mL   Sterile



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



Bottles must be stored in unit carton to protect from light.



STORAGE: Store between 2º-8ºC (36º-46ºF).



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.



INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). Preservative: benzalkonium chloride 0.01%. Inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water



pH range 4.0 to 6.0



1-800-757-9195

[email protected]

Country of Origin: Switzerland



Alcon

ALCON LABORATORIES, INC.

6201 South Freeway

Fort Worth, Texas 76134 USA 

Printed in USA

9016948-0119



SN:



LOT:



EXP:



GTIN:  00309980016156

NDC 0998-0016-15



Alcon



Alcaine^™

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



Sterile 15 mL



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



STORAGE: Store between 2º to 8ºC (36º to 46ºF).

After opening, ALCAINE^™ can be used until the expiration date on the bottle.



Bottles must be stored in unit carton to protect from light.



ALCAINE^™ (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.





INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%).





ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA     Printed in USA



LOT/EXP.:

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



Sterile 15 mL



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



STORAGE: Store between 2º-8ºC (36º-46ºF).



Bottles must be stored in unit carton to protect from light.



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.





INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%).





ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA     Printed in USA





LOT/EXP.:

NDC 0998-0016-15



Alcon



Alcaine®

(proparacaine hydrochloride ophthalmic solution USP) 0.5%



Sterile 15 mL



Rx Only



PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution.



USUAL DOSAGE: 1 or 2 drops. Read enclosed insert.



STORAGE: Store between 2º-8ºC (36º-46ºF).



Bottles must be stored in unit carton to protect from light.



ALCAINE® (proparacaine hydrochloride ophthalmic solution) should be clear to straw-color. If the solution becomes darker, discard the solution.





INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%).





ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA     Printed in USA

A Novartis Division





LOT/EXP.:



H15466-1118

Usual Dosage: Removal of foreign bodies and sutures, and for tonometry: 1 to 2 drops (in single instillations) in each eye before operating.

Short Corneal and Conjunctival Procedures: 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses.

NOTE: ALCAINE™ (proparacaine hydrochloride ophthalmic solution, USP) 0.5% should be clear to straw-color. If the solution becomes darker, discard the solution.

Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females.