NDC 43136-901 Avon Whitening Essentials Original Cool Mint

Sodium Fluoride

NDC Product Code 43136-901

NDC Code: 43136-901

Proprietary Name: Avon Whitening Essentials Original Cool Mint 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: Sodium Fluoride 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.

NDC Code Structure

  • 43136 - Tai Guk Pharm. Co., Ltd.
    • 43136-901 - Avon Whitening Essentials

NDC 43136-901-01

Package Description: 1 TUBE in 1 CARTON > 156 g in 1 TUBE

NDC Product Information

Avon Whitening Essentials Original Cool Mint with NDC 43136-901 is a a human over the counter drug product labeled by Tai Guk Pharm. Co., Ltd.. The generic name of Avon Whitening Essentials Original Cool Mint is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via dental form.

Labeler Name: Tai Guk Pharm. 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.

Avon Whitening Essentials Original Cool Mint 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.

  • SODIUM FLUORIDE 1.6 mg/g

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.

  • HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • SACCHARIN (UNII: FST467XS7D)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MICA (UNII: V8A1AW0880)
  • CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)
  • ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Tai Guk Pharm. Co., Ltd.
Labeler Code: 43136
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-31-2019 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.

Avon Whitening Essentials Original Cool Mint Product Label Images

Avon Whitening Essentials Original Cool Mint 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

Drug Facts

Drug Facts

Active Ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

Anticavity

Use

Helps protect against cavities

Warnings

Warnings

Keep Out Of Reach Of Children.

Keep out of reach of children under 6 years of age. Do not swallow. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. If an allergic reaction develops, discontinue to use immediately.

Directions

Adults and children 6 years and olderBrush teeth thoroughly after each means or at least twice a day, or as directed by a dentist and physician. Do not swallow.Children between 6 and 12 yearsTo minimize swallowing, use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.Children under 6 yearsAsk a dentist or physician.

Inactive Ingredients

Glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica, charcoal powder, citrus limon(lemon) fruit extract, sodium chloride

Otc - Questions

1-800-FOR-AVONwww.avon.com

* Please review the disclaimer below.

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