Tetracaine Hydrochloride (Page 2 of 2)

16 HOW SUPPLIED/STORAGE AND HANDLING

Tetracaine Hydrochloride Ophthalmic Solution, USP 0.5% is supplied as a sterile, aqueous, topical ophthalmic solution in a low-density polyethylene plastic dropper bottle with a low-density polyethylene dropper tip and white polypropylene cap in the following sizes:

NDC: NDC: 70518-2741-00

PACKAGING: 1 in 1 CARTON, 15 mL in 1 BOTTLE TYPE 0

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.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

17 PATIENT COUNSELING INFORMATION

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.

Repackaged By / Distributed By: RemedyRepack Inc.

625 Kolter Drive, Indiana, PA 15701

(724) 465-8762

DRUG: Tetracaine Hydrochloride

GENERIC: Tetracaine Hydrochloride

DOSAGE: SOLUTION/ DROPS

ADMINSTRATION: OPHTHALMIC

NDC: 70518-2741-0

PACKAGING: 15 mL in 1 BOTTLE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • TETRACAINE HYDROCHLORIDE 5mg in 1mL

INACTIVE INGREDIENT(S):

  • CHLOROBUTANOL
  • BORIC ACID
  • POTASSIUM CHLORIDE
  • EDETATE DISODIUM
  • WATER
  • SODIUM HYDROXIDE
  • HYDROCHLORIC ACID
Remedy_Label
(click image for full-size original)
TETRACAINE HYDROCHLORIDE
tetracaine hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2741(NDC:68682-920)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL
BORIC ACID
POTASSIUM CHLORIDE
EDETATE DISODIUM
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2741-0 1 BOTTLE in 1 CARTON contains a BOTTLE
1 15 mL in 1 BOTTLE This package is contained within the CARTON (70518-2741-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210821 05/12/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 07/2022 REMEDYREPACK INC.

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