NDC 80380-100 Sanitizing Alcohol Free Wipes

Sanitizing Alcohol Free Wipes

NDC Product Code 80380-100

NDC 80380-100-01

Package Description: 20 mg in 1 PACKET

NDC Product Information

Sanitizing Alcohol Free Wipes with NDC 80380-100 is a a human over the counter drug product labeled by Shedrain Corporation. The generic name of Sanitizing Alcohol Free Wipes is sanitizing alcohol free wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Shedrain 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.

Sanitizing Alcohol Free 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 .13 mg/100mg

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.

  • POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • XYLITOL (UNII: VCQ006KQ1E)

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: Shedrain Corporation
Labeler Code: 80380
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: 10-23-2020 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.

Sanitizing Alcohol Free 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

Active ingredient for this sanitizing alcohol-free wipes is Benzalkonium chloride.

Purpose

Hand Sanitizer to help decrease bacteria on the skin.

Use

For dispensing: Peel back front label at tab. Remove towelette wipes as needed. Reseal pouch by pressing label firmly back into place.For use: Apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash after use. Do not flush.

Warnings

For external use only.

Do Not Use

Do not use in or near the eyes. If contact occurs, flush thoroughly with water.

Otc - Stop Use

Stop use and contact doctor if redness and irritation develops and persists.

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.

Inactive Ingredients

Aqua (Water), Polyaminopropyl Biguanide, Xylitol Extract, Aloe Barbadensis Leaf Extract.

Dosage

FOR DISPENSING: Peel back front label at tab. Remove towelette wipes as needed.FOR USE: Apply thoroughly to hands asdesired. Allow to dry without wiping.

* Please review the disclaimer below.