NDC 68776-1009 Sanifect E3 Plus Hand Sanitizer

Ethyl Alcohol

NDC Product Code 68776-1009

NDC 68776-1009-1

Package Description: 4 JUG in 1 CASE > 3.8 L in 1 JUG

NDC 68776-1009-2

Package Description: 18.9 L in 1 JUG

NDC 68776-1009-3

Package Description: 208.2 L in 1 DRUM

NDC 68776-1009-4

Package Description: 6 CARTRIDGE in 1 PACKAGE > 1 L in 1 CARTRIDGE

NDC 68776-1009-5

Package Description: 113.6 L in 1 DRUM

NDC Product Information

Sanifect E3 Plus Hand Sanitizer with NDC 68776-1009 is a a human over the counter drug product labeled by Alex C. Fergusson, Inc.. The generic name of Sanifect E3 Plus Hand Sanitizer is ethyl alcohol. The product's dosage form is liquid and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1039339.

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.

Sanifect E3 Plus Hand Sanitizer 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)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Alex C. Fergusson, Inc.
Labeler Code: 68776
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: 04-27-2020 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 - NO 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".

* Please review the disclaimer below.

Sanifect E3 Plus Hand Sanitizer 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

DRUG FACTS

Otc - Active Ingredient

Active Ingredients: Ethyl Alcohol 80%

Otc - Purpose

Purpose: Antiseptic

Indications & Usage

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

Warnings

WarningsFor external use only

Other Safety Information

Flammable, keep away from fire or flame.

Other Information:Store in a cool dry place below 104°F • Recommended for use inAFCO Systems • For Food Processing, Food Service andProfessional Use Only Use Only.

Otc - When Using

​When using this product do not use in or near eyes. Discontinue use if irritation or redness develops. Use in well-ventilted area.

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

Dosage & Administration

Directions:• Place a palmful of product in one hand • Spread on both handsand rub into the skin until dry (1-2 min.) • No rinsing or towelingrequiredoweling required.

Inactive Ingredient

Inactive Ingredients:Water, isopropyl alcohol, glycerin, hydrogen peroxide, tertiary butyl alcohol*, denatonium benzoate*, citric acid**Contains one or more of these ingredients.

Otc - Questions

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

Product Package Labeling

AFCO 5324Sanifect E3 PlusHand SanitizerUN 1170, ETHANOLSOLUTIONS, 3, PG II,ER GUIDE NO. 127CHEMTREC EMERGENCY 800-424-9300(Chemtrec Customer Number: CCN837)MANUFACTURED BY:ALEX C. FERGUSSON800 DEVELOPMENT AVENUECHAMBERSBURG, PA 17201TOLL FREE: 800-345-1329NDC# 68776-1009-1BATCH NO.:EXP. DATE: CONTENTS: 1 GALLONHMIS HAZARD RATINGHEALTH                                   1FLAMMABILITY                    3REACTIVITY                          0PERSONAL PROTECTION   A1 Gal.5 Gal.55 Gal.1000 mL30 Gal.res

* Please review the disclaimer below.