NDC 0316-0292 Keri Clinical Care Hand Sanitizing Gel

Hand Sanitizer

NDC Product Code 0316-0292

NDC 0316-0292-08

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC Product Information

Keri Clinical Care Hand Sanitizing Gel with NDC 0316-0292 is a a human over the counter drug product labeled by Crown Laboratories. The generic name of Keri Clinical Care Hand Sanitizing Gel is hand sanitizer. The product's dosage form is gel and is administered via topical form.

Labeler Name: Crown Laboratories

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.

Keri Clinical Care Hand Sanitizing Gel 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 .7 mL/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.

  • DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)

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: Crown Laboratories
Labeler Code: 0316
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: 07-15-2020 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.

Keri Clinical Care Hand Sanitizing Gel Product Label Images

Keri Clinical Care Hand Sanitizing Gel 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 Ingredients

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

  • Hand sanitizer to help reduce bacteria on the skin.

Warnings

  • For external use only. Flammable. Keep away from fire or flame.Do not useOn children less than 2 months of age.On open skin wounds.When using this product avoid contact with eyes, ears, and mouth. In case of contact with eyes, rinse eyes throughly with water.
  • Stop use and ask a doctor if irritation or rash appears and lasts.

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 al surfaces. Rub hands together until dry.Supervise children under 6 years of age ehen using this prodcut to avoid swallowing.

Other Information

  • Store between 15-30°C (59-86°F). Avoid freezing. Protect frome excessive heat above 40°C (104°F). May discolor certain fabrics or surfaces.

Inactive Ingredients

Denatonium benzoate, fragrance, glycerin, polyacrylate crosspolymer-6, propanediol, purified water, tert-butyl alcohol, tocopherol acetate (vitamin E).

Questions?

800.877.8869

Manufactured And Distributed By:

Crown Laboratories, Inc.,Johnson City, TN 37604Made in USAKERI is a registred trademark of Crown Laboratoires, Inc.

Keri Clinical 8Fl Oz Label

KeriClinical CareHand Sanitizng GelRefreshing Gel with Moisurizers & Vitamin EP11827.00

* Please review the disclaimer below.