NDC 80184-997 Eyefull Pcd Kit


NDC Product Code 80184-997

NDC 80184-997-14

Package Description: 1 KIT in 1 KIT * 100 mL in 1 BOTTLE (80184-999-10) * 20 PATCH in 1 BAG (80184-996-10) > 3.5 mL in 1 PATCH

NDC 80184-997-15

Package Description: 1 KIT in 1 KIT * 100 mL in 1 BOTTLE (80184-999-11) * 20 PATCH in 1 BAG (80184-996-11) > 3.5 mL in 1 PATCH

NDC Product Information

Eyefull Pcd Kit with NDC 80184-997 is a a human over the counter drug product labeled by Rafac International Inc. The generic name of Eyefull Pcd Kit is alcohol. The product's dosage form is kit and is administered via form.

Labeler Name: Rafac International Inc

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Rafac International Inc
Labeler Code: 80184
FDA Application Number: part333E 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 08-29-2020 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.

Eyefull Pcd Kit 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

Active Ingredients

Ethyl Alcohol 75%




  • Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available


For external use only. Flammable. Keep away from heat or flame.

Stop Use And Ask A Doctor If

Irritation or rash occurs. These may be signs of a serious condition.

Do Not Use

  • On children of less than 5 year of age.On open skin wounds.

When Using This Product

Keep out of eyes,ears,and mouth.In case of contact with eyes,rinse eyes thoroughly with water.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away


  • Extract 1 wipe from pack, rub vigorously on and between fingers on both palms and hands, allow hands to dry.Discard in trash receptacle after use.Do not flush.

Other Information

  • Store in cool,dry place, between 15°-30°C(59°F-86°F).Avoid freezing and excessive heat above 40°C(104°F).

Inactive Ingredients

Purified water USP

* Please review the disclaimer below.