NDC 81339-200 Hand Sanitizing Wipe

Hand Sanitizing Wipes

NDC Product Code 81339-200

NDC 81339-200-30

Package Description: 1 mL in 1 POUCH

NDC Product Information

Hand Sanitizing Wipe with NDC 81339-200 is a a human over the counter drug product labeled by Neatgoods Llc. The generic name of Hand Sanitizing Wipe is hand sanitizing wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Neatgoods Llc

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.

Hand Sanitizing Wipe 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 65 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.

  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • WATER (UNII: 059QF0KO0R)
  • OAT (UNII: Z6J799EAJK)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CUCUMBER (UNII: YY7C30VXJT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CHAMOMILE (UNII: FGL3685T2X)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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.

Product Labeler Information

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

Labeler Name: Neatgoods Llc
Labeler Code: 81339
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: 12-28-2020 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.

Hand Sanitizing Wipe Product Label Images

Hand Sanitizing Wipe 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

Ethyl Alcohol – 65% v/v

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin when water and soap are not available.

Warnings

For external use onlyFlammable, keep away from fire or flame.When using this product, do not use in or near eyes.If contact occurs, flush thoroughly with water.Stop use and contact a doctor if irritation or redness persists for more than 72 hours.

Keep Out Of Reach Of Children

Keep out of reach of children unless under adult supervision.
If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Remove wipe.Wet hands thoroughly with wipe and allow to dry without wiping.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Althaea Officinalis Root Extract, Camellia Sinensis (White Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Lavandula Angustifolia (Lavender) Oil, Water

Label

NEATwipes
TM• 99.9% Germs Killed• 100% Biodegradable Nonwoven Material• 0% Benzalkonium Chloride30 wipe pack• Lavender Essential Oil• Glycerin & Aloe Vera• No Parabens• No TriclosanWipe measures: 6 x 7.75 inchesWarning: These wipes contain alcohol which can discolor same fabricsand surfaces. Always test an inconspicuous spot first.Disclaimer: Alcohol evaporates over time. To keep these wipes freshand effective, reseal securely sfter each use and store at 75ºF or below.Keep out of direct sunlight.Item #: 201-030-0017 53070 99972 8my NEATGOODS.COMMade in USAwith domestic and foreign componentsLEAPING BUNNY APPROVED!1% FOR THE PLANET. -MEMBER-Distributed by:NEATGOODS Lyme, CT 06371from domestic and imported ingredients

* Please review the disclaimer below.