Proparacaine Hydrochloride

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

DESCRIPTION Proparacaine hydrochloride ophthalmic solution 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 Each mL contains: Active: proparacaine hydrochloride 5mg 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: Proparacaine hydrochloride ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution.

INDICATIONS AND USAGE Proparacaine hydrochloride 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.

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

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Proparacaine Hydrochloride Proparacaine Hydrochloride PROPARACAINE HYDROCHLORIDE PROPARACAINE BENZALKONIUM CHLORIDE GLYCERIN WATER HYDROCHLORIC ACID SODIUM HYDROXIDE label carton

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

Proparacaine Hydrochloride

Proparacaine Hydrochloride

61314-016

HUMAN PRESCRIPTION DRUG

OPHTHALMIC

PRINCIPAL DISPLAY PANEL NDC 61314-016-01 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% Rx only STERILE 15 mL 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 2° to 8°C (36° to 46°F). Proparacaine hydrochloride ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution. Bottles must be stored in unit carbon to protect from light. 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. MANUFACTURED BY ALCON LABORATORIES, INC. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540 Product of Switzerland 9014663-1017 Rev.10/2017 NDC 61314-016-01 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% Rx only STERILE 15 mL SANDOZ INGREDIENTS: Each mL contains: Active: proparacaine hydrochloride 5 mg (0.5%). 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. Proparacaine hydrochloride ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Rev. 04-2012 LOT/EXP.: H14233-0216

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. *DROP-TAINER is a registered trademark of Alcon Research, Ltd. Rev. November 2021 SANDOZ Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA 300049862-1121

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 Pregnancy Category C: Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution 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 Proparacaine hydrochloride ophthalmic solution 0.5% is supplied in 15 mL DROP-TAINER* dispensers. NDC 61314-016-01 Storage: Bottle must be stored in unit carton to protect contents from light. Store bottles under refrigeration at 2° - 8°C (36° - 46°F). Rx Only

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 Pregnancy Category C: Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution 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. 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. Geriatric Use No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients