Tetracaine Hydrochloride

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is indicated for procedures requiring

a rapid and short-acting topical ophthalmic anesthetic.

One drop topically in the eye(s) as needed.

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is a clear, colorless, ophthalmic

solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.

Tetracaine Hydrochloride Ophthalmic Solution, USP, 0.5% should not be used in patients with a

history of hypersensitivity to any component of this preparation.

The following serious ocular adverse reactions are described elsewhere in the labeling:

• Corneal Injury with Intracameral Use [See Warnings and Precautions (5.1)]
• Corneal Toxicity [See Warnings and Precautions (5.2)]
• Corneal Injury due to Insensitivity [See Warnings and Precautions (5.3)]

The following adverse reactions have been identified following use of Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliable estimate their frequency or establish a causal relationship to drug exposure.

Ocular Adverse Reactions

Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort.

Prolonged use of a topical ocular anesthetic including Tetracaine Hydrochloride Ophthalmic

Solution USP, 0.5% may produce permanent corneal opacification and ulceration with

accompanying visual loss.

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is a sterile, clear, colorless, topical

local anesthetic for ophthalmic use containing tetracaine hydrochloride as the active

pharmaceutical ingredient.

Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,

2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C15H24N2O2 •

HCl and it is represented by the chemical structure:

Tetracaine hydrochloride is a fine, white, crystalline, odorless powder with a molecular weight of

300.82

Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine)

Preservative: chlorobutanol 0.4%

Inactive ingredients: boric acid, potassium chloride, edetate disodium, water for injection USP.

Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0)

Topical administration of Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% results in

localized temporary anesthesia. The maximum effect is achieved within 10–20 seconds after

instillation, with efficacy lasting 10–20 minutes. Duration of effect can be extended with

repeated dosing. [See Warnings and Precautions (5.2) and Overdosage (10)].

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is supplied as a sterile, aqueous,

topical ophthalmic solution with a fill volume of 15 mL in a 15 mL low-density polyethylene

plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap.

NDC 42702-170-15

After opening, this product can be used until the expiration date stamped on the bottle.

Storage: Store at 15°C to 25°C (59°F to 77°F). Protect from light. Do not use if solution

contains crystals, cloudy, or discolored.

Eye Care Precaution

Do not touch the dropper tip to any surface as this may contaminate the solution.

Advise patients that, due to the effect of the anesthetic, their eyes will be insensitive for up to 20

minutes and that care should be taken to avoid accidental injuries.

Manufactured for:

Paragon BioTeck, Inc.

4640 SW Macadam Ave, Ste 80

Portland, OR 97239

Manufactured and Distributed by:

Bausch & Lomb

8500 Hidden River Pkwy

Tampa, FL 33637

Revised: March 2019

NDC 42702-170-15

Paragon
BioTeck, Inc.

Tetracaine
Hydrochloride

Ophthalmic
Solution, USP
0.05% (Sterile)

Rx Only

15 mL