Alcaine

ADVERSE REACTIONS: Occasional temporary stinging, burning and conjunctival redness may occur with 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.

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

DESCRIPTION: 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. chemical

DOSAGE AND ADMINISTRATION: 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.

INDICATIONS AND USAGE: 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.

WARNINGS: 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.

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

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Alcaine proparacaine hydrochloride PROPARACAINE HYDROCHLORIDE PROPARACAINE BENZALKONIUM CHLORIDE GLYCERIN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE carton label Carton Label Container Label Container Label Carton Label

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

ANDA080027

Alcaine

proparacaine hydrochloride

0998-0016

HUMAN PRESCRIPTION DRUG

OPHTHALMIC

PRINCIPAL DISPLAY PANEL 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 alcon.medinfo@alcon.com 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 MedInfo@AlconLabs.com 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 MedInfo@AlconLabs.com 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

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

Nursing Mothers: 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.

Pediatric Use: 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.

Pregnancy: 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.

HOW SUPPLIED: 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: 09/2022 Alcon Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA © 2022 Alcon Inc. Printed in USA alcon.medinfo@alcon.com 1-800-757-9195 300056034-0222

PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenicity, or possible impairment of fertility in males or females. Pregnancy: 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.