Label: PROPARACAINE HYDROCHLORIDE - proparacaine hydrochloride solution/ drops

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 16, 2017

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  • 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.

    
chemical

    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.

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  • CLINICAL PHARMACOLOGY

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

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  • 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.

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  • CONTRAINDICATIONS

    Proparacaine hydrochloride 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

    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

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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: Proparacaine hydrochloride ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution.

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  • 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

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  • 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. June 2012

    SANDOZ

    Manufactured by
    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 for
    Sandoz Inc.
    Princeton, NJ 08540
    Printed in USA

    9007253-1011

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  • 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.
    Bottles must be stored in unit
    carton to protect from light.

    STORAGE: Store between 2°-8°C (36°-46°F). 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.

    MANUFACTURED BY ALCON LABORATORIES, INC.

    Manufactured by
    Alcon Laboratories, Inc.
    Fort Worth, Texas 76134 for
    Sandoz Inc.
    Princeton, NJ 08540

    Printed in USA

    9012981-0216

    Rev. 06/2012

    carton

    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

    label
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  • 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
    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:61314-016-01 1 in 1 CARTON 06/05/2000
    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 06/05/2000
    Labeler - Sandoz Inc. (005387188)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Research Ltd 007672236 manufacture(61314-016)
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