NDC 42702-170 Tetracaine Hydrochloride

Tetracaine Hydrochloride

NDC Product Code 42702-170

NDC 42702-170-15

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE

NDC Product Information

Tetracaine Hydrochloride with NDC 42702-170 is a a human prescription drug product labeled by Paragon Bioteck, Inc.. The generic name of Tetracaine Hydrochloride is tetracaine hydrochloride. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Paragon Bioteck, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Tetracaine Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Ophthalmic - Administration to the external eye.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Esters - [CS]
  • Local Anesthesia - [PE] (Physiologic Effect)
  • Ester Local Anesthetic - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Paragon Bioteck, Inc.
Labeler Code: 42702
FDA Application Number: NDA210821 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-12-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Tetracaine Hydrochloride Product Label Images

Tetracaine Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is indicated for procedures requiringa rapid and short-acting topical ophthalmic anesthetic.

2 Dosage And Administration

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

3 Dosage Forms And Strengths

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is a clear, colorless, ophthalmicsolution containing 0.5% w/v tetracaine hydrochloride equivalent to tetracaine 0.44% w/v.

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.

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.

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

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 mother’s 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.

10 Overdosage

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

11 Description

Tetracaine Hydrochloride Ophthalmic Solution USP, 0.5% is a 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 •HCl and it is represented by the chemical structure:Tetracaine hydrochloride is a fine, white, crystalline, odorless powder with a 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)

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.

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.

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)].

16 How Supplied/Storage And Handling

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 polyethyleneplastic dropper bottle with a 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 15°C to 25°C (59°F to 77°F). Protect from light. Do not use if solutioncontains crystals, cloudy, or discolored.

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

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