NDC 59276-602 Rapidcare Sterile Eyewash

Purified Water

NDC Product Information

Rapidcare Sterile Eyewash with NDC 59276-602 is a a human over the counter drug product labeled by Oliver Landon Intl Inc.. The generic name of Rapidcare Sterile Eyewash is purified water. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Oliver Landon Intl Inc.

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.

Rapidcare Sterile 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 98.577 mL/100mL

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.

  • POLIHEXANIDE (UNII: 322U039GMF)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)
  • SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
  • 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: Oliver Landon Intl Inc.
Labeler Code: 59276
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: 12-15-2020 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: 12-31-2021 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.

Rapidcare Sterile Eyewash Product Label Images

Rapidcare Sterile 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

Other

Drug Facts

Distributed by: Rapid Care, Inc.Carlsbad, CA 92011www.rapidcarefirstaid.comMade in U.S.A.Store out of direct sunlight.

Otc - Active Ingredient

Active ingredientPurified water 98.577%

Otc - Purpose

PurposeEyewash

Indications & Usage

Use for flushing the eye to remove loose foreign material

Warnings

WarningsFor external use only

Otc - Do Not Use

  • Do not useif solution changes color or becomes cloudyif you have open wound in or near the eyes. Get medical help right away.

Otc - When Using

  • When using this product​
  • Do not touch tip of container to any surface to avoid contaminationdo not reuse; once opened, discard

Otc - Stop Use

  • Stop use and ask a doctorifcontinued 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

Inactive Ingredient

Inactive ingredients disodium EDTA, polyhexanide 0.0001% (preservative), sodium chloride, sodium phosphate dibasic dodecahydrate, sodium phosphate monobasic dihydrate. Sodium hydroxide may be used to adjust pH.

* Please review the disclaimer below.