NDC 0924-0167 Physicians Care Eye Wash Sterile Buffered Isotonic

Water

NDC Product Code 0924-0167

NDC 0924-0167-01

Package Description: 144 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE > 30 mL in 1 BOTTLE, UNIT-DOSE

NDC 0924-0167-16

Package Description: 12 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE > 480 mL in 1 BOTTLE, UNIT-DOSE

NDC 0924-0167-32

Package Description: 12 BOTTLE, UNIT-DOSE in 1 BOX, UNIT-DOSE > 946 mL in 1 BOTTLE, UNIT-DOSE

NDC Product Information

Physicians Care Eye Wash Sterile Buffered Isotonic with NDC 0924-0167 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicians Care Eye Wash Sterile Buffered Isotonic is water. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Acme United Corporation

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc 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.

Physicians Care Eye Wash Sterile Buffered Isotonic 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.

  • WATER .98 mL/mL

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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)

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.

Product Labeler Information

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

Labeler Name: Acme United Corporation
Labeler Code: 0924
FDA Application Number: part349 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: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-29-2016 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: 12-31-2019 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’.

* Please review the disclaimer below.

Physicians Care Eye Wash Sterile Buffered Isotonic Product Label Images

Physicians Care Eye Wash Sterile Buffered Isotonic 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

Other

Drug Facts

Active Ingredient

Purified water 98%

Purpose

Eyewash

Indications

For flushing the eyes to help relieve irritation, discomfort, burning, stinging, or itching by removing loose foreign material and air pollutants (smog or pollen).

Warnings

  • For external use onlyTo avoid contamination, do not touch tip of bottle to any surfaceDo not reuseDiscard bottle after use

Do Not Use

  • If solution changes color or becomes cloudyWith contact lensesIf bottle is open or seal is broken

Stop Use And Consult A Doctor If You Experience

  • Eye painChanges in visionContinued redness or irritation of the eye or if the condition worsens or persistsObtain immediate medical treatment for all open wounds in or near the eyes.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • To pour - hold bottle securely, twist off top to removeControl rate of flow by pressure on the bottleFlush the affected eye(s) as neededDo not touch bottle tip to eyeIf necessary, continue flushing with emerengcy eyewash or shower.

Inactive Ingredients

Benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate.

Storage And Handling

Store at 59 - 86°F (15 - 30°C)

* Please review the disclaimer below.