NDC 73242-0107 Juni Essentials Naturaltoothpaste

Calcium Carbonate

NDC Product Code 73242-0107

NDC CODE: 73242-0107

Proprietary Name: Juni Essentials Naturaltoothpaste 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: Calcium Carbonate 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

  • 73242 - Dong Il Pharms Co.,ltd
    • 73242-0107 - Juni Essentials Naturaltoothpaste

NDC 73242-0107-1

Package Description: 120 g in 1 TUBE

NDC Product Information

Juni Essentials Naturaltoothpaste with NDC 73242-0107 is a a human over the counter drug product labeled by Dong Il Pharms Co.,ltd. The generic name of Juni Essentials Naturaltoothpaste is calcium carbonate. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Dong Il Pharms 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.

Juni Essentials Naturaltoothpaste 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.

  • CALCIUM CARBONATE 40 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)

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: Dong Il Pharms Co.,ltd
Labeler Code: 73242
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: 03-03-2021 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: 12-31-2022 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Juni Essentials Naturaltoothpaste Product Label Images

Juni Essentials Naturaltoothpaste 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

Calcium Carbonate

Otc - Purpose

For dental care

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Indications & Usage

Apply an appropriate amount to the toothbrush and brushing your teeth

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

Calcium Carbonate

Sorbitol

Water

Glycerin

Scutellaria Baicalensis Root Extract

Xanthan gum

Sodium Cocoyl Glutamate

Sodium Cocoyl lsethionate

Menthol

Enzymatically Modified Stevia

Xylitol

Mentha Pulegium oil

Mentha Piperita (Peppermint) Oil

Mentha Spicata Herb Oil

Sodium Chloride

Silica

Dosage & Administration

For dental use only

* Please review the disclaimer below.