NDC 75990-783 Recens Hand Sanitizer Wipes
Alcohol Cloth Topical

Product Information

What is NDC 75990-783?

The NDC code 75990-783 is assigned by the FDA to the product Recens Hand Sanitizer Wipes which is a human over the counter drug product labeled by Certus Medical, Inc.. The generic name of Recens Hand Sanitizer Wipes is alcohol. The product's dosage form is cloth and is administered via topical form. The product is distributed in a single package with assigned NDC code 75990-783-22 295 g in 1 canister . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code75990-783
Proprietary Name 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.
Recens Hand Sanitizer Wipes
Non-Proprietary Name 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.
Alcohol
Product Type 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.
Human Otc Drug
Dosage FormCloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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.
Certus Medical, Inc.
Labeler Code75990
FDA Application Number 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.
part333E
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
09-23-2011
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Recens Hand Sanitizer Wipes?


Product Packages

NDC Code 75990-783-22

Package Description: 295 g in 1 CANISTER

Product Details

What are Recens Hand Sanitizer Wipes Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Recens Hand Sanitizer Wipes Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Recens Hand Sanitizer Wipes Inactive Ingredients UNII Codes

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.

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Recens Hand Sanitizer Wipes Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Drug Facts Box Otc-Active Ingredient Section



Ethyl Alcohol 62%


Drug Facts Box Otc-Purpose Section



Antiseptic


Drug Facts Box Otc-Indications & Usage Section



for hand-washing to decrease bacteria on the skin, only when water is not available


Drug Facts Box Otc-Warnings Section



FLAMMABLE, keep away from fire and flames

For external use only


Drug Facts Box Otc-When Using Section



do not get into eyes

if contact occurs, rinse eyes thoroughly with water


Drug Facts Box Otc-Stop Use Section



irritation and redness develop


Drug Facts Box Otc-Keep Out Of Reach Of Children Section



if swallowed, get medical help or contact a Poison Control Center right away


Drug Facts Box Otc-Dosage & Administration Section



wet hands thoroughly with product and allow to dry without wiping


Drug Facts Box Otc-Inactive Ingredient Section



water, propylene glycol


Recens Hand Sanitizing Wipes 7830 70 Pre-Saturated Wipes



783070QM.jpg  Recens Hand Sanitizing Wipes  70 pre-saturated wipes 


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