NDC 80171-004 Colemerg Sanitizing Wipes

Alcohol

NDC Product Code 80171-004

NDC 80171-004-00

Package Description: 160 PATCH in 1 CANISTER > 2.6 mL in 1 PATCH

NDC Product Information

Colemerg Sanitizing Wipes with NDC 80171-004 is a a human over the counter drug product labeled by Colemerg Products Llc. The generic name of Colemerg Sanitizing Wipes is alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Colemerg Products 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.

Colemerg 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.

  • ALCOHOL .75 mL/mL

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

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: Colemerg Products Llc
Labeler Code: 80171
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: 10-25-2020 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.

Colemerg Sanitizing Wipes Product Label Images

Colemerg 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

Active Ingredients

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

  • For hand and skin sanitizing.When water, soap and towel are not available.Recommended for repeated use.

Warnings

  • For external use only.Flammable, keep away from fire or flame.

When Using This Product:

  • Do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.Use wipes only on unbroken intact skin.If you have sensitive skin or certain allergies, check the list of ingredients on the label before using wipes.Do not ingest.

Stop Use And Ask A Doctor:

If skin irritation or redness develops.

Keep Out Of Reach Of Children.

  • Children under 6 years of age use only under adult supervision.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions:

  • Not recommended for infants.

Other Information:

  • Store below 110 °F ( 43 °C)May discolor certain fabrics or surfaces.

Inactive Ingredients:

Aqua/Water, Glycerin, Propylene Glycol, Fragrance, Sodium PCA, Disodium EDTA.

* Please review the disclaimer below.