Label: TETRACAINE HYDROCHLORIDE - tetracaine hydrochloride solution

  • NDC Code(s): 0065-0741-12
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/10

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  • INSTRUCTIONS FOR USE SECTION

    Packaged in Pre-Sterilized Ready-to-Use Units—Sterile Unless Opened or Damaged

    1. STERI-UNITS® Ophthalmic Solutions may be stored under ordinary conditions and handled freely prior to opening blister pack or vial without danger of contaminating the sterile surface of the enclosed DROP-TAINER® dispenser.
    2. Open package using standard aseptic technique. The DROP-TAINER® dispenser may then be allowed to fall upon a sterile surface.
    3. The entire outer surface of the DROP-TAINER® dispenser, as well as its contents, is sterile and thus may be safely handled by the surgeon or scrub nurse. The cap of the DROP-TAINER® dispenser is quickly and easily unscrewed; and the specially designed tip needs no puncturing before use.
    4. Gentle pressure on the sides of the DROP-TAINER® dispenser will empty its contents in uniform drops.
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  • PRECAUTIONS SECTION

    Carcinogenesis, Mutagenesis, Impairment of Fertility:

    There have been no long-term studies done using Tetracaine Hydrochloride in animals to evaluate carcinogenic potential.

    Pregnancy:

    Pregnancy Category C. Animal reproduction studies have not been conducted with Tetracaine Hydrochloride. It is also not known whether these ingredients can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. STERI-UNITS® Solutions containing these ingredients should be given to a pregnant woman only if clearly needed.

    Nursing Mothers:

    It is not known whether these drugs are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Atropine Sulfate or Pilocarpine Hydrochloride is administered to a nursing woman.

    Pediatric Use:

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Use:

    No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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  • STORAGE SECTION

    Store Tetracaine Hydrochloride Ophthalmic Solution 0.5% at 46°-75° F (8° -24° C). Protect from light.

    TETRACAINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.5%

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  • DESCRIPTION SECTION

    The active ingredient is represented by the chemical structure:

    Chemical Diagram

    Established name: Tetracaine Hydrochloride
    Chemical name: Benzoic acid, 4-(butylamino)-, 2-(dimethylamino) ethyl ester, monohydrochloride.

    Each mL Contains: Active:
    Tetracaine Hydrochloride 0.5%. Inactives: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection.

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  • CLINICAL PHARMACOLOGY SECTION

    Topical anesthetics stabilize the neuronal membrane and prevent the initiation and transmission of nerve impulses thereby effecting local anesthesia. The onset of anesthesia usually begins within 30 seconds and lasts a relatively short period of time.

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  • INDICATIONS & USAGE SECTION

    For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated.

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  • CONTRAINDICATIONS SECTION

    Should not be used by the patient without physician supervision, or in those persons showing hypersensitivity to any component of this preparation.

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  • WARNINGS SECTION

    For topical eye use only, not for injection or intraocular use. Prolonged use results in diminished duration of anesthesia and retarded healing. This may cause the drug to be used more frequently, creating a “vicious circle”. Subsequent corneal infection and/or corneal opacification with accompanying permanent visual loss or corneal perforation may occur.

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  • PRECAUTIONS SECTION

    Patient should be advised not to touch or rub the eye(s) until the effect of the anesthetic has worn off.

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  • ADVERSE REACTIONS SECTION

    Transient symptoms (signs) as stinging, burning, and conjunctival redness may occur. A rare, severe, immediate type allergic corneal reaction has been reported characterized by acute diffuse epithelial keratitis with filament formation and/or sloughing of large areas of necrotic epithelium, diffuse stromal edema, descemetitis, and iritis.

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  • DOSAGE & ADMINISTRATION SECTION

    One drop topically in the eye(s) as needed. May be used during ocular surgery. Do not use intracamerally. Discard unused portion.

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  • HOW SUPPLIED SECTION

    2 mL in DROP-TAINER® dispenser in carton of 12.

    NDC
    0065-0741-12

    Rx Only

    Revised: August 2010

    9005845-0810

    Alcon Laboratories, Inc.
    6201 South Freeway
    Fort Worth, Texas 76134 USA

    1-800-757-9195
    Medinfo@AlconLabs.com
    Printed in USA
    ©2003, 2010 Alcon, Inc.

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  • PRINCIPAL DISPLAY PANEL

    NDC 0065-0741-12

    TETRACAINE HYDROCHLORIDE 0.5%
    Ophthalmic Solution

    INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%.
    Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection.
    DM-03

    USUAL DOSAGE: One drop topically in the eye(s) as needed. Discard unused portion.

    STORAGE: Store at 46 - 75F (8 - 24C). Protect from Light.
    Do not use if discolored
    Printed in USA

    Carton
    Label
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  • INGREDIENTS AND APPEARANCE
    TETRACAINE HYDROCHLORIDE  
    tetracaine hydrochloride solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0741
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tetracaine Hydrochloride (Tetracaine) Tetracaine Hydrochloride 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Sodium Chloride  
    Sodium Acetate  
    Acetic Acid  
    Water  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0065-0741-12 12 in 1 CARTON
    1 2 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/28/1969
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    Name Address ID/FEI Business Operations
    Alcon Laboratories, Inc. 008018525 MANUFACTURE(0065-0741)
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