NDC 68776-1003 Wyandotte Sanifect E3-na

Benzalkonium Chloride

NDC Product Code 68776-1003

NDC 68776-1003-2

Package Description: 3.784 L in 1 BOTTLE

NDC 68776-1003-5

Package Description: 12 BOTTLE in 1 CASE > .207 L in 1 BOTTLE

NDC Product Information

Wyandotte Sanifect E3-na with NDC 68776-1003 is a a human over the counter drug product labeled by Alex C. Fergusson, Inc.. The generic name of Wyandotte Sanifect E3-na is benzalkonium chloride. The product's dosage form is lotion and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1102185.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Wyandotte Sanifect E3-na 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)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
  • DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
  • GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)

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: part333A 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: 01-01-2011 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".

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Wyandotte Sanifect E3-na Product Label Images

Wyandotte Sanifect E3-na 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 Ingredients

DRUG FACTSACTIVE INGREDIENTS: BENZALKONIUM CHLORIDE 0.1%

Purpose Section

ANTIMICROBIAL

Keep Out Of Reach Of Children Section

KEEP OUT OF REACH OF CHILDREN. IN CASE OF ACCIDENTAL INGESTION, SEEK MEDICAL ATTENTION OF CONTACT POISON CONTROL CENTER IMMEDIATELY.

Indications And Uses Section

USESHAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASES HELPS PREVENT CROSS CONTAMINATION BT HAND CONTACTHELPS PREVENT DRYING AND CHAFFING OF SKINRECOMMENDED FOR REPEATED USE

Warnings Section

WARNINGS: FOR EXTERNAL USE ONLY  WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. IN CASE OF EYE CONTACT, FLUSH EYES WITH WATER. STOP USE AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS, OR IF CONDITION PERSISTS FOR MORE THAN 72 HOURS.

Dosage And Administration Section

DIRECTIONS: PUMP A SMALL AMOUNT OF FOAM INTO PALM OF HAND. RUB THOROUGHLY OVER ALL SURFACES OF BOTH HANDS. RUB HANDS TOGETHER BRISKLY UNTIL DRY.OTHER INFORMATION:  FOR FOOD PROCESSING, FOOD SERVICE AND PROFESSIONAL USE ONLY

Inactive Ingredient Section

WATER, CETRIMONIUM CHLORIDE, LAURTRIMONIUM CHLORIDE, DIHYDROXYETHYL COCAMINE OXIDE, GLYCERETH-17 COCOATE

Package Label

WYANDOTTE  #5581SANIFECT E3-NA HAND SANITIZERNDC# 68776-1003-2  CONTENTS: 4 X 1 GALLONBATCH NO:EXP DATE:CONTENTS:MANUFACTURED BY:ALEX C. FERGUSSON 800 DEVELOPMENT AVENUE CHAMBERSBURG, PA. 17201 TOLL FREE: 800 345-1329CHEMTREC EMERGENCY 800-424-9300(CHEMTREC CUSTOMER NUMBER: CCN837)HMIS HAZARD RATING  HEALTH 1   FLAMMABILITY 0    REACTIVITY   0   PERSONAL PROTECTION   -ALEX C. FERGUSSON800 DEVELOPMENT AVENUECHAMBERSBURG, PA. 17201TEL: 1-800-345-1329res

12 X 7 Oz. Bottle Case-Label

Res

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