Drug Facts
Composition & Profile
Identifiers & Packaging
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: 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; 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 [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
- 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: 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
- 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 [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
Overview
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
Indications & 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.
Dosage & 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.
Warnings & Precautions
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.
Contraindications
: ALCAINE™ ophthalmic solution should be considered contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.
Adverse Reactions
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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.