NDC 73112-0001 The Naked Object Deblack Packtoothpaste

Tocopherol Acetate, Silicon Dioxide

NDC Product Code 73112-0001

NDC 73112-0001-1

Package Description: 100 g in 1 TUBE

NDC Product Information

The Naked Object Deblack Packtoothpaste with NDC 73112-0001 is a a human over the counter drug product labeled by Jnk Inc. The generic name of The Naked Object Deblack Packtoothpaste is tocopherol acetate, silicon dioxide. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Jnk Inc

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.

The Naked Object Deblack Packtoothpaste 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.

  • .ALPHA.-TOCOPHEROL ACETATE .1 g/100g
  • SILICON DIOXIDE 4 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.

  • XYLITOL (UNII: VCQ006KQ1E)
  • WATER (UNII: 059QF0KO0R)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)

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: Jnk Inc
Labeler Code: 73112
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: 05-10-2019 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.

The Naked Object Deblack Packtoothpaste Product Label Images

The Naked Object Deblack Packtoothpaste 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

Silicon dioxide, tocopherol acetate

Otc - Purpose

For dental careActivated Charocal helps removing bad breath, stains, and plaque. Keeps your mouth clean, whiter and firm. Refreshes your mouth and prevents tooth decay, gingivitis, periodontal disease, periodontal disease, gum disease.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

A proper amount of toothpaste is put on the toothbrush and the tooth is cleaned by brushing.Cover your teeth with toothpaste using toothbrush(paste it on teeth). Wait for 1~2minute to let it absorb smell and stains. Afterwards, brush your teeth just like normal toothpaste.

Warnings

Storage method1. Keep it at room temperature in a classified container.2. Cover and store at room temperature.3. Store in a not moisture and cool place.4. Air may come out during use of this product, but there is no problem with its weight.Usage Precautions1. Be careful not to swallow. Rinse mouth thoroughly after use2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.5. Keep out of the reach of children under 6 years of age.

Inactive Ingredient

Silicon dioxide

Tocopherol acetate

Pyridoxine hydrochloride

glycerin

Sorbitol solution

Cellulose Gum

Ascorbic acid

Sodium cocoyl glutamate

Xylitol

Enzymatically Modified Stevia Glucosyl Stevia

Activated Charcoal/Carbon

Grapefruit Seed Extract

Aloe Extract

Camomile Extract

Greentea Extract

Centella Asiatica Extract

Calendula Extract

Rosemary Extract

L-Menthol

Eucalyptus Oil

Spearmint oil

water

Dosage & Administration

For dental use only

* Please review the disclaimer below.