NDC 60637-230 Justice Berry Scented Anti-bacterial Hand Sanitizer

Alcohol

NDC Product Code 60637-230

NDC Code: 60637-230

Proprietary Name: Justice Berry Scented Anti-bacterial Hand Sanitizer 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: Alcohol 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

  • 60637 - Tween Brands, Inc.
    • 60637-230 - Justice Berry Scented Anti-bacterial Hand Sanitizer

NDC 60637-230-00

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Justice Berry Scented Anti-bacterial Hand Sanitizer with NDC 60637-230 is a a human over the counter drug product labeled by Tween Brands, Inc.. The generic name of Justice Berry Scented Anti-bacterial Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Tween Brands, 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.

Justice Berry Scented Anti-bacterial 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 620 mg/mL

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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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: Tween Brands, Inc.
Labeler Code: 60637
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: 04-19-2019 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: 12-31-2020 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.

Justice Berry Scented Anti-bacterial Hand Sanitizer Product Label Images

Justice Berry Scented Anti-bacterial 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

Alcohol 62%

Purpose

Antiseptic

Use

  • For hand washing to decrease bacteria on the skin.Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame.For external use only

Do Not Use

In the eyes or apply over large areas of the body.In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.Use only as directed. Do not drink. If taken internally, it will produce serious gastric disturbances

Stop Use And Ask A Doctor If

Irritation persists for more than 72 hours.

Keep Out Of Reach Of Children.

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

Directions

  • Wet hands thoroughly with product and allow to dry without wipingSupervise children in the use of this product

Other Information

  • Store below 105°F (40.5° C).May discolor some fabrics. Expiry Date:06/2023

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Fragrance Carbomer, Triethanolamine, Polyethylene Terephthalate, Acrylates Copolymer, Blue 1, Yellow 5.

* Please review the disclaimer below.

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