NDC 78898-675 Nimbus9 Advanced Alcohol Wipes Pouch 80pcs

Ethyl Alcohol

NDC Product Code 78898-675

NDC CODE: 78898-675

Proprietary Name: Nimbus9 Advanced Alcohol Wipes Pouch 80pcs What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ethyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 78898 - Eco Wipes Vietnam Corporation
    • 78898-675 - Nimbus9 Advanced Alcohol Wipes Pouch 80pcs

NDC 78898-675-80

Package Description: 80 PATCH in 1 POUCH > 3.6 mL in 1 PATCH

NDC Product Information

Nimbus9 Advanced Alcohol Wipes Pouch 80pcs with NDC 78898-675 is a a human over the counter drug product labeled by Eco Wipes Vietnam Corporation. The generic name of Nimbus9 Advanced Alcohol Wipes Pouch 80pcs is ethyl alcohol. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Eco Wipes Vietnam 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.

Nimbus9 Advanced Alcohol Wipes Pouch 80pcs 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/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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • WATER (UNII: 059QF0KO0R)

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: Eco Wipes Vietnam Corporation
Labeler Code: 78898
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: 08-26-2020 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.

Nimbus9 Advanced Alcohol Wipes Pouch 80pcs Product Label Images

Nimbus9 Advanced Alcohol Wipes Pouch 80pcs 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[S]

Ethyl alcohol 75% v/v

​Purpose

Consumer antiseptic

​Warnings

​Flammable. Keep away from fire or flame.For external use only.Do not use on open skin wounds​When using this product ​do not use in the eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.​Discontinue use ​ if irritation and redness develop. If condition persists for more than 72 hours consult a doctor

​Other Information

• Store between 15-30C (59-86F)• Avoid freezing and excessive heat above 40C (104F)

* Please review the disclaimer below.