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NDC 61314-0016-01 Proparacaine Hydrochloride 5 mg/mL Details

Proparacaine Hydrochloride 5 mg/mL

Proparacaine Hydrochloride is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc.. The primary component is PROPARACAINE HYDROCHLORIDE.

Product Information

NDC	61314-0016
Product ID	61314-016_ca203740-1e54-4289-9a1f-f2086fec4f46
Associated GPIs	86750020102005
GCN Sequence Number	007859
GCN Sequence Number Description	proparacaine HCl DROPS 0.5 % OPHTHALMIC
HIC3	Q6H
HIC3 Description	EYE LOCAL ANESTHETICS
GCN	32850
HICL Sequence Number	003460
HICL Sequence Number Description	PROPARACAINE HCL
Brand/Generic	Generic
Proprietary Name	Proparacaine Hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	Proparacaine Hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	5
Active Ingredient Units	mg/mL
Substance Name	PROPARACAINE HYDROCHLORIDE
Labeler Name	Sandoz Inc.
Pharmaceutical Class	Local Anesthesia [PE], Local Anesthetic [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA080027
Listing Certified Through	2024-12-31

Package

Package Images

NDC 61314-0016-01 (61314001601)

Pricing Information	N/A
NDC Package Code	61314-016-01
Billing NDC	61314001601
Package	1 BOTTLE in 1 CARTON (61314-016-01) / 15 mL in 1 BOTTLE
Marketing Start Date	2000-06-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 447a2a64-0507-4fe8-bb44-cc36c3916151 Details

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.

CLINICAL PHARMACOLOGY

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

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.

CONTRAINDICATIONS

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

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.

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

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.

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.

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

SPL UNCLASSIFIED SECTION

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

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

INGREDIENTS AND APPEARANCE

PROPARACAINE HYDROCHLORIDE

proparacaine hydrochloride solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:61314-016
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROPARACAINE HYDROCHLORIDE (UNII: U96OL57GOY) (PROPARACAINE - UNII:B4OB0JHI1X)	PROPARACAINE HYDROCHLORIDE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61314-016-01	1 in 1 CARTON	06/05/2000
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA080027	06/05/2000

Labeler - Sandoz Inc. (005387188)

Registrant - Alcon Laboratories, Inc. (008018525)

Name	Address	ID/FEI	Business Operations
Establishment
Alcon Research LLC		007672236	manufacture(61314-016)

Revised: 6/2022

Document Id: ca203740-1e54-4289-9a1f-f2086fec4f46

Set id: 447a2a64-0507-4fe8-bb44-cc36c3916151

Version: 6

Effective Time: 20220629