NDC 0869-0482 Alcohol-free Anticavity

Sodium Fluoride

NDC Product Code 0869-0482

NDC 0869-0482-86

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Alcohol-free Anticavity with NDC 0869-0482 is a a human over the counter drug product labeled by Vi-jon, Llc. The generic name of Alcohol-free Anticavity is sodium fluoride. The product's dosage form is liquid and is administered via oral form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Alcohol-free Anticavity 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.


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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

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.

Product Labeler Information

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

Labeler Name: Vi-jon, Llc
Labeler Code: 0869
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: 02-01-2013 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Alcohol-free Anticavity Product Label Images

Alcohol-free Anticavity 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 Ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Warnings

Keep Out Of Reach Of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 6 years of age and older:use twice daily after brushing your teeth with a toothpastevigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervisionchildren under 6 years of age: consult a dentist or doctor

Inactive Ingredients

Water, glycerin, cetylpyridinium chloride, flavor, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Other

Sealed with printed neckband for your protectionMountain falls fluroide mouth wash*Ths product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Advanced Anticavity Fluoride Rinse.This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurence.Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114Questions or comments? 1-888-593-0593Made in the USA with US and foreign parts.

* Please review the disclaimer below.