Label: ALCAINE - proparacaine hydrochloride solution/ drops

  • NDC Code(s): 0998-0016-15
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 25, 2018

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  • 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:

    
chemical

    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.

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  • CLINICAL PHARMACOLOGY:

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

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  • 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.

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  • CONTRAINDICATIONS:

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

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • Geriatric Use:

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

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  • 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.

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  • 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.

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  • 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-46°F).

    Rx Only

    © 2004, 2018 Novartis


    Distributed by:

    ALCON LABORATORIES, INC.

    Fort Worth, Texas 76134


    Alcon®

    A Novartis company


    Revised: April 2018

    T2018-46

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  • 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-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

    ©2001, 2004, 2009 Alcon, Inc.
    1-800-757-9195
    MedInfo@AlconLabs.com

    Alcon®
    ALCON LABORATORIES, INC.
    6201 South Freeway

    Fort Worth, Texas 76134 USA     
    Printed in USA

    359039-0509

    LOT:

    EXP.:

    
carton

    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
    © 2001, 2004 Alcon, Inc.

    LOT/EXP.:

    H12934-0813

    label

      

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  • INGREDIENTS AND APPEARANCE
    ALCAINE  
    proparacaine hydrochloride solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0998-0016
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PROPARACAINE HYDROCHLORIDE (UNII: U96OL57GOY) (PROPARACAINE - UNII:B4OB0JHI1X) PROPARACAINE HYDROCHLORIDE 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0998-0016-15 1 in 1 CARTON 10/19/1973
    1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA080027 10/19/1973
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Siegfried AG 482824026 API MANUFACTURE(0998-0016) , ANALYSIS(0998-0016)
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