NDC 80290-001 Finch Stat-75 Wipes

Ethyl Alcohol

NDC Product Code 80290-001

NDC 80290-001-75

Package Description: 160 PACKAGE in 1 CANISTER > 3.438 mL in 1 PACKAGE

NDC Product Information

Finch Stat-75 Wipes with NDC 80290-001 is a a human over the counter drug product labeled by New Pig Corporation. The generic name of Finch Stat-75 Wipes is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: New Pig Corporation

Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.

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.

Finch Stat-75 Wipes 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.

  • ALCOHOL 75 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE (UNII: V5VD430YW9)
  • POLYURETHANE-35 (NOT MORE THAN 500 MPA.S AT 40%) (UNII: Q2LKX89BE0)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: New Pig Corporation
Labeler Code: 80290
FDA Application Number: part333A 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: 08-27-2020 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.

Finch Stat-75 Wipes Product Label Images

Finch Stat-75 Wipes 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 Ingredient(S)

75% Ethyl Alcohol

Purpose

Antiseptic

Use(S)

Disinfecting wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.Do not use• in children less than 2 months of age• on open skin woundsWhen using this product keep out of eyes, ears, and mouth.In case of contact with eyes, rinse eyes thoroughly with water.Stop use and ask a doctor if irritation or rash occurs.These may be signs of a serious condition.

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 start the feed: Remove the canister lid and discard the plastic seal from the canister. Open the   plastic bag containing the towel roll. From the center of the toweled roll, pull up wipe and thread it   through the hole in the lid. Place the lid back on top of the canister. Pull the wipe through   approximately 1 inch.   Keep lid closed tightly to avoid excess evaporation.• Wipe down hands, fingers, in-between digits areas and wrists thoroughly with the wipe. Utilize the   entire surface of the wipe. Allow ample time to dry.• Discard the wipe after single use.• Supervise children under 6 years of age when using this product.

Other Information

Alcohol is a volatile substance. Keep the container in a cool and dry place, avoiding direct sunlight or fire.• Store between 15-30C (59-86F)• Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredient(S)

Non-Woven fabric, Pure water, Glycerin, Aloe Extract, Polyurethane.

* Please review the disclaimer below.