NDC 80925-202 Honest-paste

Precipitated Calcium Carbonate

NDC Product Code 80925-202

NDC CODE: 80925-202

Proprietary Name: Honest-paste 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: Precipitated 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

  • 80925 - Boonco Co., Ltd

NDC 80925-202-01

Package Description: 120 g in 1 TUBE

NDC Product Information

Honest-paste with NDC 80925-202 is a a human over the counter drug product labeled by Boonco Co., Ltd. The generic name of Honest-paste is precipitated calcium carbonate. The product's dosage form is paste and is administered via dental form.

Labeler Name: Boonco Co., Ltd

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Honest-paste 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 30 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.

  • SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
  • GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
  • MYRRH (UNII: JC71GJ1F3L)
  • SAGE (UNII: 065C5D077J)
  • XYLITOL (UNII: VCQ006KQ1E)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • SPEARMINT OIL (UNII: C3M81465G5)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • CITRUS MAXIMA SEED (UNII: 083X55C543)
  • PROPOLIS WAX (UNII: 6Y8XYV2NOF)
  • CHAMOMILE (UNII: FGL3685T2X)
  • SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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.
  • 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: Boonco Co., Ltd
Labeler Code: 80925
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: 10-28-2020 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.

Honest-paste Product Label Images

Honest-paste 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

Precipitated calcium carbonate 30%

Purpose

Anticavity

Use

Helps protect against cavities

Warnings

When using this product, avoid contact with eyes and lips. If contact occurs, rinse with water.

Stop Use And Ask A Dentist If

Irritation or redness develops.

Keep Out Of Reach Of Children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 6 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician.children under 6 years of age: consult a dentist or physician

Inactive Ingredients

Glycerin, silicon dioxide, cellulose gum, xanthan gum, sodium cocoyl glutamate, xylitol, green tea extract, licorice root extract, calendula extract, chamomile extract, sage extract, grapefruit seed extract, enzyme treatment stevia, myrrh, propolis extract, aloe extract, l-menthol, spearmint oil, peppermint oil, eucalyptus oil, sodium pyrophosphate, purified water

* Please review the disclaimer below.