Tetracaine hydrochloride ophthalmic solution, 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, 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, 0.5%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably 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, 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 only 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 white crystalline 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 dihydrate, water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH (3.7 – 6.0).

Topical administration of tetracaine hydrochloride ophthalmic solution, 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 in a white LDPE bottle, plugged with white LDPE nozzle and capped with white HDPE cap in the following sizes:

NDC 70069-596-01, 5 mL fill in 5 mL Bottle

NDC 70069-597-01, 15 mL fill in 15 mL Bottle

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

Storage: Store at 15° to 25°C (59° 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:

Somerset Therapeutics, LLC

Somerset, NJ 08873

Made in India

Code No.: KR/DRUGS/KTK/28/289/97

ST-TEC/P/00

1200992

Container Label

NDC 70069-596-01

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%     

Sterile

Rx only

5 mL

Carton Label

NDC 70069-596-01

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%     

Sterile

Rx only

5 mL

Container Label

NDC 70069-597-01

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%     

Sterile

Rx only

15 mL

Carton Label

NDC 70069-597-01

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5%     

Sterile

Rx only

15 mL