NDC 73065-0004 Hae Yan Tooth

Precipitated Calcium Carbonate, Aluminum Chlorohydroxy Allantoinate, Aminocaproic Acid, Dibasic Calcium Phosphate Hydrate

NDC Product Code 73065-0004

NDC CODE: 73065-0004

Proprietary Name: Hae Yan Tooth 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, Aluminum Chlorohydroxy Allantoinate, Aminocaproic Acid, Dibasic Calcium Phosphate Hydrate 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 help control bleeding due to a condition where your blood does not clot the way it normally should (fibrinolysis). This may cause serious bleeding after certain surgeries or in certain conditions (such as bleeding disorders, liver disease, cancer). Aminocaproic acid works by helping your blood clot normally. It belongs to a class of drugs known as antifibrinolytics.
  • 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

  • 73065 - Woorilife&health

NDC 73065-0004-1

Package Description: 130 g in 1 TUBE

NDC Product Information

Hae Yan Tooth with NDC 73065-0004 is a a human over the counter drug product labeled by Woorilife&health. The generic name of Hae Yan Tooth is precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate. The product's dosage form is paste and is administered via oral form.

Labeler Name: Woorilife&health

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.

Hae Yan Tooth 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.

  • AMINOCAPROIC ACID .09 g/100g
  • DIBASIC CALCIUM PHOSPHATE DIHYDRATE .09 g/100g
  • CALCIUM CARBONATE 37 g/100g
  • ALCLOXA .09 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)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Woorilife&health
Labeler Code: 73065
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: 05-25-2020 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’.

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Hae Yan Tooth Product Label Images

Hae Yan Tooth 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

Precipitated calcium carbonate, aminocaproic acid, aluminium chlorohydrin allantoinate, dibasic calcium phosphate hydrate

Inactive Ingredient

D-sorbitol solution, glycerin, silica, roasted salt, xanthan gum, carboxymethylcellulose sodium, sodium lauryl sulfate, grapefruit seed extract, sodium saccharin, xylitol, l-menthol, green tea extract, propolis extract, glycyrrhiza extract, mulberry root extract, peppermint oil, purified water

Otc - Purpose

Aids in the prevention of dental cavities.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

  • Adults and children 2 years of age and olderBrush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or docter.Children under 6 yearsTo minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.Children under 2 years Consult a dentist or doctor

Warnings

1) Be careful not to swallow it, and rinse your mouth thoroughly after use.2) If any abnormalities such as gum or mouth damage are caused by using this toothpaste, stop using the product and consult a doctor or dentist.3) For children under 6 years of age, use a small amount of pea toothpaste per serving and use it under the supervision of a guardian to avoid sucking or swallowing.4) If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.5) Keep out of reach of children under 6 years old.

Dosage & Administration

For external use only

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