NDC 64950-021 Delsan Hand Sanitizer With Vitamin E

Alcohol

NDC Product Code 64950-021

NDC 64950-021-02

Package Description: 59 mL in 1 BOTTLE

NDC 64950-021-08

Package Description: 237 mL in 1 BOTTLE

NDC Product Information

Delsan Hand Sanitizer With Vitamin E with NDC 64950-021 is a a human over the counter drug product labeled by Genus Lifesciences Inc.. The generic name of Delsan Hand Sanitizer With Vitamin E is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Genus Lifesciences Inc.

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.

Delsan Hand Sanitizer With Vitamin E 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 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.

  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • BETAINE (UNII: 3SCV180C9W)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Genus Lifesciences Inc.
Labeler Code: 64950
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: 10-29-2020 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.

Delsan Hand Sanitizer With Vitamin E 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

Distributed by: Genus Lifesciences Inc. Allentown, PA 18102

Active Ingredient

‡ Ethyl alcohol 70% v/v

Purpose

Antiseptic

Use

  • Hand Sanitizer to help reduce bacteria that potentially can cause disease

Warnings

Flammable. Keep away from heat or flameFor external use only - hands

Do Not Use

  • In 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 skin irritation or rash appears and lasts. 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 right away.

Directions

  • Place enough product in your palm to cover hands and rub hands together briskly until dry.Children under 6 years of age should be supervised when using this product.

Other Information

  • Store between 15 - 30°C (59 - 86°F)Avoid freezing and excessive heat above 40°C (104°F)May discolor certain fabricsMay be harmful to wood finishes and plastics

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer contains one or more of these ingredients, Aminomethyl propanol, Betaine , Diisopropyl adipate, Fragrance, Glycerin, Purified water, Vitamin E acetate

Questions?

Call Pharm-Olam at 1-866-511-6754

* Please review the disclaimer below.