NDC 80362-076 Mea Protect Wipes

62% Alcohol Wipes

NDC Product Code 80362-076

NDC 80362-076-80

Package Description: 148 mL in 1 POUCH

NDC Product Information

Mea Protect Wipes with NDC 80362-076 is a a human over the counter drug product labeled by Guardsman Global Llc.. The generic name of Mea Protect Wipes is 62% alcohol wipes. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Guardsman Global 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.

Mea Protect 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 62 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)

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: Guardsman Global Llc.
Labeler Code: 80362
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: 10-26-2020 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.

Mea Protect 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 IngredientEthyl Alcohol 62% v/v

Purpose

PurposeAntiseptic

Use

UseDecreases bacteria on the skin

Warnings

WarningsFor external use only

Do Not Use

Do not useIf you are allergic to any of the ingredients.

When Using This Product

When using this productDo not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor

Stop use and ask a doctorIf irritation or rash develops and continues for more than 72 hours

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

DirectionsAdults and children2 years and over •apply to hands •allow to dry without wipingChildren under 2 years •ask a doctor before use

Inactive Ingredients

Inactive IngredientsIsopropyl Alcohol, Purified Water

Questions

Questions or Comments?Call +1 800-835-9744

Package Label

CLEANS. SANITIZES. KILLS 99.9% OF GERMS.* MEA protect75% Alcohol Wipes MADE IN USA*Germs commonly found on hands.80 Alcohol Wipes6.0 in x 8.0 in (15 cm x 20 cm)75% Alcohol Wipes80 Alcohol Wipes6.0 in x 8.0 in (15 cm x 20 cm) SAFE ON HANDS800-833-0044www.meausa.comMEA MARKETING, LLC.6741 Whitestone RoadBaltimore, MD 21207+1 800-833-0044clientcare@measusa.comwww.MEAUSA.com©2020 MEA Marketing, Inc.All Rights ReservedPRODUCT CONTENTS: SpunlaceNon-woven Fabric, 75% Ethyl AlcoholCAUTION: Once removed from pack, use immediately to avoid loss of moisture.STORAGE: Store in a cool, dry place.USAGE: Open the pack and wipe the desired area with tissue.CONTENTS: Multipurpose Alcohol WipesSIZE: 6.0in x 8.0inNOT INTENDED FOR MEDICAL USEBarcode: 8 60005 42070 4MEA Protect Wipes NDC 80362-076-80

* Please review the disclaimer below.