PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. Container LabelNDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only mLCarton LabelNDC 70069-596-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only mLContainer LabelNDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mLCarton LabelNDC 70069-597-01 Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% Sterile Rx only 15 mL. Image. Image. Image. Image.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Safety of tetracaine hydrochloride ophthalmic solution, 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution, 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, 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, 0.5% in pregnant women. Animal developmental and reproductive toxicity studies with tetracaine hydrochloride have not been reported in the published literature.

RECENT MAJOR CHANGES SECTION.

RECENT MAJOR CHANGES. Warnings and Precautions (5.4) 2/2022.

SPL UNCLASSIFIED SECTION.

SPL UNCLASSIFIED. Manufactured for:Somerset Therapeutics, LLCSomerset, NJ 08873Made in IndiaCode No.: KR/DRUGS/KTK/28/289/97ST-TEC/P/001200992.

ADVERSE REACTIONS SECTION.

6 ADVERSE REACTIONS. 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 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.. 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)]. Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort. (6)To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 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, 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, 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, 0.5% should not be used in patients with history 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, 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 white crystalline powder with 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).. Image.

DOSAGE & ADMINISTRATION SECTION.

2 DOSAGE AND ADMINISTRATION. One drop topically in the eye(s) as needed.. One drop topically in the eye(s) as needed. (2).

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.. Ophthalmic solution containing 0.5% tetracaine hydrochloride. (3).

GERIATRIC USE SECTION.

8.5 Geriatric Use. No overall differences in safety or effectiveness of tetracaine hydrochloride ophthalmic solution, 0.5% have been observed between elderly and younger patients.

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 white LDPE bottle, plugged with white LDPE nozzle and capped with white HDPE cap in the following sizes:NDC 70069-596-01, mL fill in mL BottleNDC 70069-597-01, 15 mL fill in 15 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.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. Tetracaine hydrochloride ophthalmic solution, 0.5% is indicated for procedures requiring rapid and short-acting topical ophthalmic anesthetic.. Tetracaine hydrochloride ophthalmic solution, 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.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Tetracaine blocks sodium ion channels required for the initiation and conduction of neuronal impulses thereby affecting local anesthesia.

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, 0.5% may produce permanent corneal opacification and ulceration with accompanying visual loss.

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, 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, 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, 0.5% and any potential adverse effects on the breastfed child from tetracaine hydrochloride ophthalmic solution, 0.5%.. 8.3 Females and Males of Reproductive Potential. No human data on the effect of tetracaine hydrochloride ophthalmic solution, 0.5% on fertility are available.. 8.4 Pediatric Use. Safety of tetracaine hydrochloride ophthalmic solution, 0.5% in the pediatric population has been demonstrated in clinical trials. Efficacy of tetracaine hydrochloride ophthalmic solution, 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, 0.5% have been observed between elderly and younger patients.

WARNINGS AND PRECAUTIONS SECTION.

5 WARNINGS AND PRECAUTIONS. Do not use intracamerally since use may damage corneal endothelial cells. (5.1)Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. (5.2)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. (5.3)For Administration by Healthcare Provider Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is not intended for patient self- administration. (5.4). Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage. (5.2). 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. (5.3). For Administration by Healthcare Provider Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is not intended for patient self- administration. (5.4). 5.1 Corneal Injury with Intracameral Use. Not for injection or intraocular use. Do not use intracamerally because use of tetracaine hydrochloride ophthalmic solution, 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.. 5.4 For Administration by Healthcare Provider. Tetracaine hydrochloride ophthalmic solution, 0.5% is indicated for administration under the direct supervision of healthcare provider. Tetracaine Hydrochloride Ophthalmic Solution, 0.5% is not intended for patient self-administration [see Warnings and Precautions (5.2)].