NDC 81240-001 Nimbus

Benzalkonium Chloride

NDC Product Code 81240-001

NDC 81240-001-50

Package Description: 30 mL in 1 PACKAGE

NDC Product Information

Nimbus with NDC 81240-001 is a a human over the counter drug product labeled by Nimbus Eco Inc.. The generic name of Nimbus is benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.

Labeler Name: Nimbus Eco Inc.

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.

Nimbus 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 .12 mg/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.

  • CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
  • ALCOHOL (UNII: 3K9958V90M)
  • BRONOPOL (UNII: 6PU1E16C9W)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • 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: Nimbus Eco Inc.
Labeler Code: 81240
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: 12-09-2020 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.

Nimbus Product Label Images

Nimbus 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

Other

  • This is a hand sanitizing wipe manufactured using only the following United States Pharmacopoeia (USP) grade ingredientsBenzalkonium Chloride (USP grade) (0.12%, volume/volume (v/v))Water
  • C. Propylene Glycol
  • D. Ethyl Alcohol
  • E. Lauryl Glucoside
  • F. Phenoxyethanol
  • G. Tetrasodium EDTA
  • H. 3-Iodo-2-Propynyl ButylCarbamate
  • I. 2-Bromo-2-Nitropropane-1,3-Diol
  • J. Citric Acid
  • K. Fragrance
  • L. Aloe Barbadensis Leaf Extract
  • M. Chamomilla Recutita Flower Extract

Active Ingredient(S)

Benzalkonium Chloride 0.1% Purpose: Antibacterial

Purpose

Antibacterial

Use

Decrease bacteria on the skin

Warnings

For external use only.

Do Not Use

Do not use if irritation and redness develop

Otc - When Using

When using this product avoid contact with eyes, if contact occurs, rinse thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if condition persists for more than 72 hours.

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.

Directions

Open resealable label. Remove one wipe to use. Wipe hands thoroughly with product and allow to dry without wiping.Close resealable label after use to retain moisture.

Other Information

Dispose of wipe in the proper containerDo not flush down the toiletKill claims against: Escherichia Coli and Staphylococcus aureus

Inactive Ingredients

Water

Propylene Glycol

Ethyl Alcohol

Lauryl Glucoside

Phenoxyethanol

Benzalkonium Chloride

Tetrasodium EDTA

3-Iodo-2-Propynyl ButylCarbamate

2-Bromo-2-Nitropropane-1,3-Diol

Citric Acid

Fragrance N/A

Aloe Barbadensis Leaf Extract

Chamomilla Recutita Flower Extract

* Please review the disclaimer below.