NDC 76801-866 Eagle Wipes Hand Sanitizing Wipes

Benzalkonium Chloride

NDC Product Code 76801-866

NDC 76801-866-80

Package Description: 100 g in 1 PACKAGE

NDC Product Information

Eagle Wipes Hand Sanitizing Wipes with NDC 76801-866 is a a human over the counter drug product labeled by Texas Ragtime Inc. The generic name of Eagle Wipes Hand Sanitizing Wipes is benzalkonium chloride. The product's dosage form is swab and is administered via topical form.

Labeler Name: Texas Ragtime Inc

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Eagle Wipes Hand Sanitizing 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.

  • BENZALKONIUM CHLORIDE .0013 g/g

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Texas Ragtime Inc
Labeler Code: 76801
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: 09-01-2020 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.

Eagle Wipes Hand Sanitizing 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

Otc - Purpose

Antimicrobial

Warnings

For External Use only.Do not use In eyes.Do not use if you are allergic to any of the ingredients.When using this product if eye contact occurs, rinse eyes thoroughlv with water.Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Otc - Do Not Use

In eyesIf you are allergic to any of the ingredients.

Otc - Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control center immediately.

Dosage And Administration

Directions:To Begin:Make a small cut along top of refill pouch to open and expose wipes. Keep wipes in pouch. Pinch center wipe from pouch and pull up through wipe dispenser opening. Place entire pouch into dispenser and close.For use:Gently pull wipe(s) from dispenser feed. Dispose wipe after each use. DO NOT FLUSH.

Otc - Active Ingredient

Benzalkonium Chloride

Inactive Ingredients

EthylhexylglycerinHexylene GlycolPolysorbate 20Propylene GlycolCitric Acid MonohydrateAloe Vera LeafWater

Indications & Usage

AntibacterialFor hand washing to decrease bacteria on the skin. May be used on hands.

* Please review the disclaimer below.