NDC 76123-100 School Health Hand Sanitizer Unscented

Benzalkonium Chloride

NDC Product Code 76123-100

NDC 76123-100-64

Package Description: 1892 mL in 1 BOTTLE, PUMP

NDC Product Information

School Health Hand Sanitizer Unscented with NDC 76123-100 is a a human over the counter drug product labeled by School Health Corporation. The generic name of School Health Hand Sanitizer Unscented is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: School Health Corporation

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.

School Health Hand Sanitizer Unscented 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.

  • BENZALKONIUM CHLORIDE .13 g/100mL

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)
  • COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: School Health Corporation
Labeler Code: 76123
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: 05-05-2021 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: 12-31-2022 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.

School Health Hand Sanitizer Unscented Product Label Images

School Health Hand Sanitizer Unscented 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 0.13%

Purpose

Antiseptic Hand Sanitizer

Use

  • To decrease bacteria on the skin

Warnings

For external use only.

Keep Out Of Reach Of Children.

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

Do Not Use In Eyes.

In case of contact, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If

Skin/eye irritation develops.

Directions

Liberally apply product to skin by gently massaging until absorbed. Supervise children in the use of the product.

Other Information

  • Avoid extreme temperatures

Inactive Ingredients

Water, Cocamidolpropyl PG-Dimonium Chloride Phospate,Propylene glycol, Triethylene glycol, Polysorbate-20, FD&C Blue No. 1, Fragrance

Package Labeling

SCOOL HEALTH®HAND SANITIZERALCOHOL FREEHAND SANITIZERUnscented, 64 fl oz• Kills 99% of germs• Non-toxic• MoisturizingUnscented64 fl oz (1,892 mL)ScoolHealth.com866.323.5465Manufactured for School Health Corporation, 56oo Apollo Dr., Rolling Meadows. IL 60008Made in the USAres

* Please review the disclaimer below.