NDC 79987-201 Advanced Hand Sanitizer

Isopropyl Alcohol

NDC Product Code 79987-201

NDC 79987-201-01

Package Description: 30 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-02

Package Description: 59 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-03

Package Description: 100 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-04

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-05

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-06

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-07

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-08

Package Description: 1892 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-09

Package Description: 3785 mL in 1 BOTTLE, PLASTIC

NDC 79987-201-10

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Advanced Hand Sanitizer with NDC 79987-201 is a a human over the counter drug product labeled by Yugen Pharmaceuticals, Llc. The generic name of Advanced Hand Sanitizer is isopropyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Yugen Pharmaceuticals, Llc

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Advanced 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.

  • ISOPROPYL ALCOHOL 70 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.

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

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: Yugen Pharmaceuticals, Llc
Labeler Code: 79987
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: 08-26-2020 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.

Advanced Hand Sanitizer Product Label Images

Advanced 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

Active Ingredient[S]

Isopropyl alcohol 70% v/v

Purpose

Antiseptic

Use[S]

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 Not Use

  • In children less than 2 months of ageon open skin wounds

When Using This Product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

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

Directions

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

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Glycerin, hydrogen peroxide, purified water USP

Company Information

YUGEN PHARMACEUTICALS122 W 27th Street, 11th FloorNew York, NY 10001

Product Packaging - 250 Ml

Yugen PHARMACEUTICALSADVANCEDHAND SANITIZERALCOHOL 70% GEL FORMULAHelps Kill GermsMoisturizingUnscentedMADE IN U.S.A.USP GRADE8.5 FL OZ / 250 ML

* Please review the disclaimer below.