NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

OVERDOSAGE SECTION.

10 OVERDOSAGE Prolonged use of topical ocular anesthetic including Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Carton mL. NDC 0187-0920-05Rx onlyTetracaineHydrochlorideOphthalmicSolution, USP0.05% (Sterile)5 mLBAUSCH Health. C:\Users\dale.iannetti\OneDrive Valeant Pharmaceuticals North America, LLC\Documents\SPL Assignments\2020\Tetracaine B&L\carton.jpg.

PEDIATRIC USE SECTION.

8.4 Pediatric Use Safety of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

PREGNANCY SECTION.

8.1 Pregnancy Risk SummaryThere are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

SPL UNCLASSIFIED SECTION.

5.1 Corneal Injury with Intracameral Use Not for injection or intraocular use. Do not use intracamerally because use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may lead to damage of the corneal endothelial cells.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is indicated for procedures requiring rapid and short-acting topical ophthalmic anesthetic.. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, is an ester local anesthetic indicated for procedures requiring rapid and short-acting topical ophthalmic anesthetic. (1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING INFORMATION Eye Care PrecautionDo 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.Distributed by:Bausch Health US, LLCBridgewater, NJ 08807 USAManufactured by:Bausch Lomb IncorporatedTampa, FL 33637 USA(C) 2020 Bausch Health Companies Inc. or its affiliates9xxxxxx (Folded)9xxxxxx (Flat).

LACTATION SECTION.

8.2 Lactation Risk SummaryThere are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is excreted in human milk or to assess its effects on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling:oCorneal Injury with Intracameral Use [See Warnings and Precautions (5.1)]oCorneal Toxicity [See Warnings and Precautions (5.2)]oCorneal 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 population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure.Ocular Adverse ReactionsTransient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort.. oCorneal Injury with Intracameral Use [See Warnings and Precautions (5.1)]. oCorneal Toxicity [See Warnings and Precautions (5.2)]. oCorneal Injury due to Insensitivity [See Warnings and Precautions (5.3)]. Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. (6)To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies to assess the genotoxicity of tetracaine hydrochloride have not been reported in the published literature. Long-term animal studies have not been conducted to evaluate the carcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects of tetracaine hydrochloride on fertility have not been reported in the published literature.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.. 12.3 Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% has not been studied. Tetracaine hydrochloride is metabolized by plasma pseudocholinesterases and nonspecific esterases in ocular tissues.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES 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)].

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% should not be used in patients with history of hypersensitivity to any component of this preparation.. Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%, should not be used in patients with history of hypersensitivity to any component of this preparation. (4).

DESCRIPTION SECTION.

11 DESCRIPTION Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is 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 oHCl and it is represented by the chemical structure:Tetracaine hydrochloride is fine, white, crystalline, odorless powder with molecular weight of300.82Active 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).. chemstructure.jpg.

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is clear, colorless, ophthalmic solution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.. Sterile, preserved, ophthalmic solution containing 0.5% tetracaine hydrochloride. (3).

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/STORAGE AND HANDLING Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied as sterile, aqueous, topical ophthalmic solution in low-density polyethylene plastic dropper bottle with low-density polyethylene dropper tip and white polypropylene cap in the following sizes: NDC 0187-920-055 mL in 7.5 mL BottleAfter opening, this product can be used until the expiration date stamped on the bottle.Storage: Store at 15 to 25C (59 to 77F). Protect from light. Do not use if solution contains crystals, cloudy, or discolored.. NDC 0187-920-055 mL in 7.5 mL Bottle.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk SummaryThere are no adequate and well-controlled studies with Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.. 8.2 Lactation Risk SummaryThere are no data to assess whether Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is excreted in human milk or to assess its effects on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% and any potential adverse effects on the breastfed child from Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5%.. 8.3 Females and Males of Reproductive Potential No human data on the effect of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% on fertility are available.. 8.4 Pediatric Use Safety of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% for use in pediatric patients has been extrapolated from adequate and well controlled clinical trials in the adult population.. 8.5 Geriatric Use No overall differences in safety or effectiveness of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% have been observed between elderly and younger patients.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS oDo not use intracamerally since use may damage corneal endothelial cells. (5.1)oProlonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. (5.2)oPatients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. (5.3). oDo not use intracamerally since use may damage corneal endothelial cells. (5.1). oProlonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. (5.2). oPatients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. (5.3). 5.1 Corneal Injury with Intracameral Use Not for injection or intraocular use. Do not use intracamerally because use of Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% may lead to damage of the corneal endothelial cells.. 5.2 Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage.. 5.3 Corneal Injury due to Insensitivity Patients should not touch the eye for at least 10-20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye.