NDC 59004-010 Hand Sanitizer

Hand Sanitizer

NDC Product Code 59004-010

NDC 59004-010-01

Package Description: 59 mL in 1 BOTTLE

NDC Product Information

Hand Sanitizer with NDC 59004-010 is a a human over the counter drug product labeled by Jacent Strategic Merchandising, Llc. The generic name of Hand Sanitizer is hand sanitizer. The product's dosage form is gel and is administered via extracorporeal form.

Labeler Name: Jacent Strategic Merchandising, 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.

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 44.25 mL/59mL

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)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • CHAMOMILE (UNII: FGL3685T2X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE (UNII: V5VD430YW9)
  • TROLAMINE (UNII: 9O3K93S3TK)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Extracorporeal - Administration outside of the body.
  • Extracorporeal - Administration outside of the body.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Jacent Strategic Merchandising, Llc
Labeler Code: 59004
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: 06-01-2020 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

Dosage & Administration

Store below 110°F Avoid direct sunlight,fluorescent lighting, heat, and moisture.

Inactive Ingredient

Pure Water, Carbomer U21 (C10-30 Alkanol acrylate cros-inked polymer), Glycerin, Aloe extract,Chamomile Scent, Triethanolamine.

Indications & Usage

1.Adults and children over 2 years: Supervise children when they use this product2.For occasional and personal domestic use.3.Rub thoroughly into hands for at least 30 seconds. Allow to dry.

Otc - Active Ingredient

Ethyl Alcohol

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Otc - Purpose

Disinfection

Sterilization

Warnings

1.For external use only

2.When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

3.Stop use and ask / consult a doctor / physician 1 health care practitioner I health care provider/ health care professional if iritation develops.

4.Keep out of reach of children.If swallowed, call a poison control centre or get medical help right away,

* Please review the disclaimer below.