NDC 74177-964 Tonka Digger Berry Hand Sanitizer

Alcohol

NDC Product Code 74177-964

NDC 74177-964-01

Package Description: 1 KIT in 1 KIT * 89 mL in 1 BOTTLE, PLASTIC * 3.4 g in 1 TUBE * 89 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Tonka Digger Berry Hand Sanitizer with NDC 74177-964 is a a human over the counter drug product labeled by K7 Design Group Inc.. The generic name of Tonka Digger Berry Hand Sanitizer is alcohol. The product's dosage form is kit and is administered via form.

Labeler Name: K7 Design Group Inc.

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Labeler Information

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

Labeler Name: K7 Design Group Inc.
Labeler Code: 74177
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: 12-11-2020 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.

Tonka Digger Berry Hand Sanitizer Product Label Images

Tonka Digger Berry 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 69% v/v

Purpose

Antiseptic

Use

For hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

For external use onlyFlammable, keep away from fire and flames

When Using This Product

  • Do not get into eyes.if contact occurs, rinse eyes thoroughly with water

Stop Use And Ask A Doctor If

  • Irritation and redness develop

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 wiping

Other Information

  • Store at 68F to 77F (20C - 25C)Do not store above 110F (43C)You may report a serious adverse reaction to this product to Report Reaction, LLC, PO Box 22, Plainsboro, NJ 08536

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Carbomer, Aloe Barbadensis Leaf Extract, Aminomethyl Propanol, Fragrance, Tocopheryl Acetate, Denatonium Benzoate, Yellow 5, Blue 1.

Company Information

MANUFACTURED FOR & DIST. BY K7 DESIGN GROUP LLC2433 KNAPP ST. BROOKLYN, NY 11235

* Please review the disclaimer below.