Dosage Form | Package Information | Links |
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SOLUTION | 1 BOTTLE, DROPPER in 1 CARTON (24208-920-64) > 15 mL in 1 BOTTLE, DROPPER | Label Information |
Tetracaine Hydrochloride is a sterile aqueous topical anesthetic ophthalmic solution. The active ingredient is represented by the chemical structure:
C15H24N2O2·HCI
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%.
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.
After instillation of this product, the surface of the eye is insensitive and can be scratched without feeling it. Do not rub eye. Do not instill this product repeatedly because severe eye damage may occur.
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.
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.
TETRACAINE HYDROCHLORIDE tetracaine hydrochloride solution |
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Labeler - Bausch & Lomb Incorporated (196603781) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Bausch & Lomb Incorporated | 079587625 | MANUFACTURE(24208-920) |