Label: PROPARACAINE HYDROCHLORIDE- proparacaine hydrochloride solution/ drops

  • NDC Code(s): 24208-730-06
  • Packager: Bausch & Lomb Incorporated
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 27, 2016

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • DESCRIPTION

    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

    Proparacaine Hydrochloride (structural formula)

    Molecular weight: 330.85

    Each mL contains:

    Active: proparacaine hydrochloride 5 mg (0.5%). Inactives: glycerin and purified water. The pH may be adjusted with hydrochloric acid and/or sodium hydroxide. Preservative: benzalkonium chloride (0.01%).

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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 is contraindicated in patients with known hypersensitivity to any of the ingredients of this preparation.

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  • WARNINGS

    NOT FOR INJECTION INTO THE EYE - 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, 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.

    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 of 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 been reported.

    To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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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, USP 0.5% should be clear, colorless to faint yellow color. If the solution becomes darker, discard the solution.

    FOR TOPICAL OPHTHALMIC USE ONLY

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  • HOW SUPPLIED

    Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following size:

    NDC 24208-730-06 – 15 mL bottle

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  • Storage

    Refrigerate at 2°-8°C (36°- 46°F). Protect from light. Keep tightly closed.

    DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

    KEEP OUT OF REACH OF CHILDREN.

    Revised: July 2016

    Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA

    ©Bausch & Lomb Incorporated

    9114403 (Folded)
    9114503 (Flat)

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  • PRINCIPAL DISPLAY PANEL

    Carton.jpg

    NDC 24208-730-06

    Proparacaine
    Hydrochloride
    Ophthalmic
    Solution, USP 0.5%

    (Sterile)

    FOR TOPICAL OPHTHALMIC
    USE ONLY

    Rx only

    15 mL

    BAUSCH + LOMB

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  • INGREDIENTS AND APPEARANCE
    PROPARACAINE HYDROCHLORIDE 
    proparacaine hydrochloride solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-730
    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)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-730-06 1 in 1 CARTON 09/29/1995
    1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA040074 09/29/1995
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-730)
    Establishment
    Name Address ID/FEI Business Operations
    Siegfried Ltd 482824026 API MANUFACTURE(24208-730)
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