Label: TETRACAINE HYDROCHLORIDE solution
Contains inactivated NDC Code(s)
NDC Code(s): 76413-127-15
- Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 24208-920
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 20, 2016
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- Official Label (Printer Friendly)
Tetracaine Hydrochloride is a sterile aqueous topical anesthetic ophthalmic solution. The active ingredient is represented by the chemical structure:
Mol. wt. 300.83
Benzoic acid, 4-[butylamino]-, 2-[dimethylamino]ethyl ester, monohydrochloride.
EACH mL CONTAINS: ACTIVE: Tetracaine Hydrochloride 5 mg (0.5%); INACTIVES: Boric Acid, Potassium Chloride, Edetate Disodium and Purified Water. Sodium Hydroxide and/or Hydrochloric Acid may be added to adjust pH (3.7 - 6.0). PRESERVATIVE ADDED: Chlorobutanol 0.4%.
- CLINICAL PHARMACOLOGY:
- INDICATIONS AND USAGE:
FOR TOPICAL USE ONLY—NOT FOR INJECTION. To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding area with the dropper tip. Patient should be advised not to touch or rub the eye(s) until the effect of the anesthetic has worn off.
Transient symptoms (signs) such as stinging, burning and conjunctival redness may occur. A rare, severe, immediate allergic cornea 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 AND ADMINISTRATION:
For tonometry and other procedures of short duration, instill one or two drops just prior to evaluation. For minor surgical procedures such as foreign body or suture removal, administer one to two drops every five to ten minutes for one to three instillations. For prolonged anesthesia as in cataract extraction, instill one or two drops in the eye(s) every five to ten minutes for three to five doses.
- HOW SUPPLIED:
PRINCIPAL DISPLAY PANEL - 15 ML Bottle Label
CommUnity Care Federally Qualified Centers
**FOR CLINIC USE ONLY**
**SINGLE USE ONLY**
TETRACAINE OPHT 0.5% SOL15 ML NDC 76413-127-15
Bausch & Lomb
Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
INGREDIENTS AND APPEARANCE
tetracaine hydrochloride solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76413-127(NDC:24208-920) 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 BORIC ACID (UNII: R57ZHV85D4) POTASSIUM CHLORIDE (UNII: 660YQ98I10) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYDROCHLORIC ACID (UNII: QTT17582CB) CHLOROBUTANOL (UNII: HM4YQM8WRC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76413-127-15 1 in 1 CARTON 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 Unapproved drug other 09/30/1990 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-127) , RELABEL(76413-127)