NDC 60319-3001 Noble G Plus

Xylitol

NDC Product Code 60319-3001

NDC 60319-3001-1

Package Description: 130 g in 1 TUBE

NDC Product Information

Noble G Plus with NDC 60319-3001 is a a human over the counter drug product labeled by Hankuk Bowonbio Co., Ltd. The generic name of Noble G Plus is xylitol. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Hankuk Bowonbio Co., Ltd

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

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.

Noble G Plus 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.

  • XYLITOL .7 g/100g

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)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SORBITOL (UNII: 506T60A25R)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)
  • GOLD (UNII: 79Y1949PYO)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
  • CHITOSAN OLIGOSACCHARIDE (UNII: 23R93M6Y64)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Hankuk Bowonbio Co., Ltd
Labeler Code: 60319
Marketing Category: UNAPPROVED DRUG OTHER - 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: 11-30-2012 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Noble G Plus Product Label Images

Noble G Plus 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

Otc - Active Ingredient

Active ingredient:  xylitol

Inactive Ingredient

Silicone dioxide, sodium monofluorophosphate, hydrated silicone dioxide, d-sorbitol, carboxymethylcellulose sodium, sodium lauryl sulfate, sodium saccharin, gold leaf, green tea extract, polyethylene glycol 1500, L-menthol, hydroxyapatite, chitosan, stearic acid, polysorbate 80, water

Otc - Purpose

Whiten and strong teethremoval of bad breathprevention of gingivitis and periodontitisprevention of periodontal diseases and gum diseasesremoval of dental plaque

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Apply Proper Amount of the toothpaste on the tooth.

Warnings

■ For tooth only.■ Avoid contact with eyes.■ Do not swallow. If swallowed, get medical help.

Dosage & Administration

Brush your teeth by putting appropriate amount of tooth paste

* Please review the disclaimer below.