Your browser does not support JavaScript! TETRACAINE HYDROCHLORIDE (TETRACAINE HYDROCHLORIDE) SOLUTION [ALCON LABORATORIES, INC.]
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TETRACAINE HYDROCHLORIDE (tetracaine hydrochloride) solution
[Alcon Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

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.

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%

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.

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.

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

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

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.

PRECAUTIONS SECTION

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

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.

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.

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.

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
TETRACAINE HYDROCHLORIDE  
tetracaine hydrochloride solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0065-0741
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tetracaine Hydrochloride (Tetracaine) Tetracaine Hydrochloride5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride 
Sodium Acetate 
Acetic Acid 
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-0741-1212 in 1 CARTON
12 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/28/1969
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Laboratories, Inc.008018525MANUFACTURE(0065-0741)

Revised: 8/2010
 
Alcon Laboratories, Inc.

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