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
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated August 1, 2010
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- INSTRUCTIONS FOR USE SECTION
Packaged in Pre-Sterilized Ready-to-Use Units—Sterile Unless Opened or Damaged
- 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.
- Open package using standard aseptic technique. The DROP-TAINER® dispenser may then be allowed to fall upon a sterile surface.
- 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.
- Gentle pressure on the sides of the DROP-TAINER® dispenser will empty its contents in uniform drops.
- 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 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.
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.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
- 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%Close
- DESCRIPTION SECTION
The active ingredient is represented by the chemical structure:
Established name: Tetracaine HydrochlorideClose
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.
- 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.Close
- INDICATIONS & USAGE SECTION
For procedures in which a rapid and short-acting topical ophthalmic anesthetic is indicated.Close
- CONTRAINDICATIONS SECTION
Should not be used by the patient without physician supervision, or in those persons showing hypersensitivity to any component of this preparation.Close
- 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.Close
- PRECAUTIONS SECTION
Patient should be advised not to touch or rub the eye(s) until the effect of the anesthetic has worn off.Close
- 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.Close
- 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.Close
- HOW SUPPLIED SECTION
2 mL in DROP-TAINER® dispenser in carton of 12.
Revised: August 2010
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134 USA
Printed in USA
©2003, 2010 Alcon, Inc.
- PRINCIPAL DISPLAY PANEL
TETRACAINE HYDROCHLORIDE 0.5%
INGREDIENTS: Each mL contains: Active: Tetracaine Hydrochloride 0.5%.
Inactive: Sodium Chloride, Sodium Acetate Trihydrate, Acetic Acid (to adjust pH), Water for Injection.
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
- INGREDIENTS AND APPEARANCE
tetracaine hydrochloride solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0065-0741 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Tetracaine Hydrochloride (UNII: 5NF5D4OPCI) (Tetracaine - UNII:0619F35CGV) Tetracaine Hydrochloride 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Sodium Chloride (UNII: 451W47IQ8X) Sodium Acetate (UNII: 4550K0SC9B) Acetic Acid (UNII: Q40Q9N063P) Water (UNII: 059QF0KO0R) 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)