NDC 77490-079 On-the-spot Hand Sanitizer Original

Hand Sanitizer Spray

  1. Labeler Index
  2. On The Spot Products, Llc
  3. NDC: 77490-079 On-the-spot Hand Sanitizer Original

NDC Product Code 77490-079

NDC CODE: 77490-079

Proprietary Name: On-the-spot Hand Sanitizer Original 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.
Non-Proprietary Name: Hand Sanitizer Spray 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.

NDC Code Structure

NDC 77490-079-01

Package Description: 60 mL in 1 BOTTLE, SPRAY

NDC 77490-079-02

Package Description: 100 mL in 1 BOTTLE, SPRAY

NDC 77490-079-03

Package Description: 235 mL in 1 BOTTLE, SPRAY

NDC Product Information

On-the-spot Hand Sanitizer Original with NDC 77490-079 is a a human over the counter drug product labeled by On The Spot Products, Llc. The generic name of On-the-spot Hand Sanitizer Original is hand sanitizer spray. The product's dosage form is spray and is administered via topical form.

Labeler Name: On The Spot Products, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

On-the-spot Hand Sanitizer Original 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 75 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.
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • WATER (UNII: 059QF0KO0R)
  • DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)

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: On The Spot Products, Llc
Labeler Code: 77490
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: 12-21-2020 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.

On-the-spot Hand Sanitizer Original Product Label Images

On-the-spot Hand Sanitizer Original 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

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame. Do no use: on children less than 2 months of age on open skin wounds. When in use: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

Otc - Do Not Use

Do no use: on children less than 2 months of age on open skin wounds.

Otc - When Using

When in use: 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 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 Poison Control Center right away.

Directions

Place enough product on hands to cover all surfaces. Rub hand together until dry. Supervise children under age 6 when using this product to avoid swallowing.

Other Information

May discolor fabrics or surfaces. Avoid excessive heat. Store below 105℉(40℃).

Inactive Ingredients

Water(Aqua), BHT, Denatonium Benzoate, Tert-Butyl Alohol.

* Please review the disclaimer below.