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 thepublished literature. Long-term animal studies have not been conducted to evaluate thecarcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects oftetracaine hydrochloride on fertility have not been reported in the published literature.

OVERDOSAGE SECTION.

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

PEDIATRIC USE SECTION.

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

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of TetracaineHydrochloride Ophthalmic Solution USP, 0.5% has not been studied. Tetracaine hydrochloride ismetabolized 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 OphthalmicSolution USP, 0.5% in pregnant women. Animal developmental and reproductive toxicity studieswith 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 TetracaineHydrochloride Ophthalmic Solution USP, 0.5% may lead to damage of the corneal endothelialcells.

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 reliable 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 Lomb, Division of Valeant Pharmaceuticals North America 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 thepublished literature. Long-term animal studies have not been conducted to evaluate thecarcinogenic potential of tetracaine hydrochloride. Animal studies to assess the effects oftetracaine 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 neuronalimpulses thereby affecting local anesthesia.. 12.3 Pharmacokinetics The systemic exposure to tetracaine following topical ocular administration of TetracaineHydrochloride Ophthalmic Solution USP, 0.5% has not been studied. Tetracaine hydrochloride ismetabolized 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 inlocalized temporary anesthesia. The maximum effect is achieved within 10-20 seconds afterinstillation, with efficacy lasting 10-20 minutes. Duration of effect can be extended withrepeated 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 ahistory of hypersensitivity to any component of this preparation.. Tetracaine Hydrochloride Ophthalmic Solution, 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, topicallocal anesthetic for ophthalmic use containing tetracaine hydrochloride as the activepharmaceutical 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, water for injection USP.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, ophthalmicsolution 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 with fill volume of 15 mL in 15 mL low-density polyethyleneplastic dropper bottle with low-density polyethylene dropper tip and white polypropylene cap.NDC 42702-170-15After opening, this product can be used until the expiration date stamped on the bottle.Storage: Store at 15C to 25C (59F to 77F). Protect from light. Do not use if solutioncontains crystals, cloudy, or discolored.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is indicated for procedures requiringa 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 20minutes and that care should be taken to avoid accidental injuries.Manufactured for:Paragon BioTeck, Inc.4640 SW Macadam Ave, Ste 80Portland, OR 97239Manufactured and Distributed by:Bausch Lomb8500 Hidden River PkwyTampa, FL 33637Revised: March 2019.

LACTATION SECTION.

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

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 OphthalmicSolution USP, 0.5% in pregnant women. Animal developmental and reproductive toxicity studieswith 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% isexcreted in human milk or to assess its effects on milk production/excretion. The developmentaland health benefits of breastfeeding should be considered along with the mothers clinical needfor Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% and any potential adverse effectson 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% onfertility are available.. 8.4 Pediatric Use Safety of Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% in the pediatric populationhas been demonstrated in clinical trials. Efficacy of Tetracaine Hydrochloride OphthalmicSolution USP, 0.5% for use in pediatric patients has been extrapolated from adequate and wellcontrolled clinical trials in the adult population.. 8.5 Geriatric Use No overall differences in safety or effectiveness of Tetracaine Hydrochloride OphthalmicSolution 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 TetracaineHydrochloride Ophthalmic Solution USP, 0.5% may lead to damage of the corneal endothelialcells.. 5.2 Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelialdefects 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 accidentalinjuries can occur due to insensitivity of the eye.