NDC 68776-1001 Wyandotte Sanifect E3
Alcohol Lotion Topical

Product Information

Product Code68776-1001
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.
Wyandotte Sanifect E3
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 FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Alex C. Fergusson, Inc.
Labeler Code68776
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.
10-01-2006
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.
12-31-2022
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

Usage Information


Product Packages

NDC 68776-1001-1

Package Description: 3.784 L in 1 BOTTLE

NDC 68776-1001-2

Package Description: 208 L in 1 DRUM

Product Details

Wyandotte Sanifect E3 is a human over the counter drug product labeled by Alex C. Fergusson, Inc.. The generic name of Wyandotte Sanifect E3 is alcohol. The product's dosage form is lotion and is administered via topical form.


What are Wyandotte Sanifect E3 Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)


* Please review the disclaimer below.

Wyandotte Sanifect E3 Labeling and Warnings

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.

Table of Contents



Wyandotte Sanifect E3 Hand Sanitizer Label



WYANDOTTE SANIFECT E3 HAND SANITIZER  ETHANOL SOLUTIONS, 3, UN 1170, PG II ER GUIDE NO. 127  #5511

NDC # 68776-1001-4  CONTENTS 55 GALLONS  HMIS HAZARD RATING HEALTH-1 FLAMMABILITY-3 REACTIVITY-0 PERSONAL PROTECTION -

ACTIVE INGREDIENTS: ETHYL ALCOHOL 60.1%............... PURPOSE: ANTIMICROBIAL  INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL

QUESTIONS OR COMMENTS - FOR PRODUCT OR TECHNICAL INFORMATION, CONTACT AFCO MONDAY TO FRIDAY 8 AM TO 4 PM EST AT 1-800-345-1329 OR VISIT OUR WEBSITE AT WWW.AFCOCARE.COM

WYANDOTTE ALEX C. FERGUSSON 800 DEVELOPMENT AVE CHAMBERSBURG, PA 17201 TEL: 1-800-345-1329




Drug Facts Active Ingredients:



Ethyl Alcohol 60.1%


Purpose:



Antimicrobial


Keep Out Of Reach Of Children:



Keep out of reach of children.

In Case of accidental ingestion, seek medical attention or contact poison control center immediately.


Uses



  • Hand wash to help reduce bacteria that potentially can cause diseases.
  • Helps prevent cross contamination by hand contact
  • Helps prevent drying and chaffing of skin
  • Recommended for repeat use

Warnings:



For external use only - Flammable, keep away from fire or flame.


When Using This Product:



Do not use in or near eyes - Use in well ventilated area - Discontinue use if irritation and redness develops


Directions:



Place a palmful of product in one hand. Spread on both hands and rub into the skin until dry (1 - 2 min.). No rinsing or toweling required


Other Information:



Store in a cool dry place below 104 F - Recommended for use in AFCO Systems - For Food Processing, Food Service and Professional Use Only


Inactive Ingredients:



Water, isopropyl alcohol, glycerin, carbomer, aminomethyl propanol


Questions Or Comments:



For product or technical information, contact AFCO Monday to Friday 8 AM to 4 PM EST at 1-800-345-1329 or visit our website at www.afcocare.com


* Please review the disclaimer below.