NDC 71338-225 Ecolab Antiseptic

Benzalkonium Chloride

NDC Product Code 71338-225

NDC 71338-225-71

Package Description: 20 PACKET in 1 BOX > 1.4 mL in 1 PACKET

NDC Product Information

Ecolab Antiseptic with NDC 71338-225 is a a human over the counter drug product labeled by Ecolab Food Safety Specialties, Inc.. The generic name of Ecolab Antiseptic is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Ecolab Food Safety Specialties, 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.

Ecolab Antiseptic 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.


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)

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: Ecolab Food Safety Specialties, Inc.
Labeler Code: 71338
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: 11-01-2019 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.

Ecolab Antiseptic Product Label Images

Ecolab Antiseptic 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

Benzalkonium Chloride, 0.133%




First aid to help reduce the risk of infection in minor cuts, scrapes and burns.


For external use only.

Do Not Use

  • In the eyes or over large areas of the body

Ask A Doctor Before Use If You Have

  • Deep punture wounds, animal bites or serious burns

Stop Use And Ask A Doctor If

  • If the condition persists or gets worse

Keep Out Of Reach Of Children.

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


  • Tear open packet, unfold and clean the affected area

Other Information

  • Store at room temperature 59°-86°F (15°-30°C)tamper evident sealed packetsdo not use any open or torn packets

Inactive Ingredients

Sodium bicarbonate, water

Ecolab Antiseptic Wipes Label

ANSI/ISEA RequiredECOLAB® Antiseptic WipesBenzalonium chloride 0.133%Reorder # 2220 ectra large wipes per boxTamper Evident Sealed Packets

* Please review the disclaimer below.