NDC 0924-0165 Physicianscare Eye Wash

Water

NDC Product Code 0924-0165

NDC 0924-0165-01

Package Description: 30 mL in 1 BOTTLE

NDC 0924-0165-16

Package Description: 480 mL in 1 BOTTLE

NDC 0924-0165-32

Package Description: 946 mL in 1 BOTTLE

NDC Product Information

Physicianscare Eye Wash with NDC 0924-0165 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of Physicianscare Eye Wash 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.

Physicianscare Eye Wash 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: 12-05-2014 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 Eye Wash Product Label Images

Physicianscare Eye Wash 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 IngredientPurified Water 98%

Otc - Purpose

PurposeEyewash

Indications & Usage

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

Warnings

  • Warnings: For External Use OnlyTo avoid contamination, do not touch tip of bottle to any surfaceDo not reuseDiscard bottle after use

Otc - Do Not Use

  • Do Not Use:If solution changes color or becomes cloudyWith contact lensesIf bottle is open or seal is broken

Otc - Stop Use

  • Stop use and consult a doctor if you experience: Eye pain Changes in vision Continued 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.

Dosage & Administration

  • 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 emergency eyewash or shower.

Inactive Ingredient

Inactive Ingredients:Benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasicheptahydrate, sodium phosphate monobasic monohydrate.

Otc - Questions

Questions or Comments?  Call Toll Free: 800-835-2263Store at 59 - 86°F (15 - 30°C)

* Please review the disclaimer below.