NDC 76537-001 Hand Sanitizer

Ethanol

NDC Product Code 76537-001

NDC 76537-001-01

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC 76537-001-02

Package Description: 118 mL in 1 BOTTLE, SPRAY

NDC 76537-001-03

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Hand Sanitizer with NDC 76537-001 is a a human over the counter drug product labeled by Nano Technology Solutions. The generic name of Hand Sanitizer is ethanol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Nano Technology Solutions

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.

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.

  • ALCOHOL 80 mL/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.

  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Nano Technology Solutions
Labeler Code: 76537
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: 05-05-2020 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 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.

Hand Sanitizer Product Label Images

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

NANO TECHNOLOGY SOLUTIONS1212 Maple Drive, Suite BTroy, MI 48083(248) 234-4201

Otc - Active Ingredient

Active ingredientAlcohol 80% v/v

Otc - Purpose

Purpose
Antiseptic

Indications & Usage

  • Useshand sanitizer to help reduce bacteria that potentially can cause diseasefor use when soap and water are not available

Warnings

Warnings
For external use only.

Flammable. Keep away from heat or flame.

Otc - Do Not Use

  • Do not usein children less than 2 months of ageon open skin wounds

Otc - When Using

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

  • Directionsplace enough product on hands to cover all surfacesrub hands together until drysupervise children under 6 years of age when using this product to avoid swallowing

Storage And Handling

  • Other informationstore between 15-30°C (59-86°F)avoid freezing and excessive heat above 40“C (104°F)

Inactive Ingredient

Inactive ingredients glycerin, hydrogen peroxide, purified water USP

* Please review the disclaimer below.