NDC 0924-0160 Physicianscare Ophthalmic Solution Eyewash

Purified Water 98.3%

NDC Product Code 0924-0160

NDC 0924-0160-01

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

NDC 0924-0160-04

Package Description: 118 mL in 1 BOTTLE, UNIT-DOSE

NDC Product Information

Physicianscare Ophthalmic Solution Eyewash with NDC 0924-0160 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicianscare Ophthalmic Solution Eyewash is purified water 98.3%. 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.

Physicianscare Ophthalmic Solution Eyewash 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 929 g/946mL

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.

  • BORIC ACID (UNII: R57ZHV85D4)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: NDA022305 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: 06-12-2013 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’.

* Please review the disclaimer below.

Physicianscare Ophthalmic Solution Eyewash Product Label Images

Physicianscare Ophthalmic Solution Eyewash 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

Otc - Active Ingredient

Active Ingredients Purified Water 98.3%

Otc - Purpose

PurposeEyewash

Indications & Usage

UseFor cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

  • WarningsFor external use only Do not useif you experience any open wounds in or near the eyes and obtain immediate medical treatmentif solution changes color or becomes cloudy When using this productto avoid contamination, do not touch tip of container to any surfacedo not reuseonce opened, discard Stop use and ask a doctor if you experiencechanges in visioneye paincondition worsens or persistscontinued redness or irritation of the eye

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.

Dosage & Administration

DirectionsFlush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle.

Information For Patients

  • Other informationlot number is printed on the bottlestore at 20° to 25° C [68° to 77° F]for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL"do not use if this seal is missing or brokenuse before expiration date marked on bottle

Inactive Ingredient

Inactive ingredientsboric acid, sodium borate, sodium chloride

Otc - Questions

Questions?  Call   1-800-835-2263

* Please review the disclaimer below.