NDC 75990-6968 Recens Foam

Alcohol

NDC Product Code 75990-6968

NDC Code: 75990-6968

Proprietary Name: Recens Foam 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: 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

  • 75990 - Certus Medical, Inc.
    • 75990-6968 - Recens Foam

NDC 75990-6968-2

Package Description: 1000 mL in 1 BAG

NDC 75990-6968-5

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC 75990-6968-7

Package Description: 700 mL in 1 BAG

NDC 75990-6968-8

Package Description: 50 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Recens Foam with NDC 75990-6968 is a a human over the counter drug product labeled by Certus Medical, Inc.. The generic name of Recens Foam is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Certus Medical, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Recens Foam 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 .7 mL/mL

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: Certus Medical, Inc.
Labeler Code: 75990
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: 07-09-2019 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: 12-31-2020 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.

Recens Foam Product Label Images

Recens Foam 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

Drug Facts Box Otc-Active Ingredient Section

Ethyl Alcohol 62% v/v

Drug Facts Box Otc-Purpose Section

Antiseptic

Drug Facts Box Otc-Indications & Usage Section

For hand-washing to decrease bacteria on the skinif hands are visibly soiled, use regular soap and waterrecommended for repeated use

Drug Facts Box Otc-Warnings Section

FLAMMABLE, keep away from fire and flamesFor external use only

Drug Facts Box Otc-When Using Section

Do not get into eyesif 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

Apply to hands and rub lightly until dry without wiping or rinsing

Drug Facts Box Otc-Inactive Ingredient Section

Water, DEA-C8-18 perfluoroalkylethyl phosphate, propylene glycol

Recens Foam 6968 1000Ml

6968M8PM.jpg  Recens Foam  1000ml

* Please review the disclaimer below.

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