NDC 49035-213 Anticavity
Sodium Fluoride Rinse Oral

Product Information

Product Code49035-213
Proprietary Name 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.
Anticavity
Non-Proprietary Name 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.
Sodium Fluoride
Product Type 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.
Human Otc Drug
Dosage FormRinse - A liquid used to cleanse by flushing.
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.
Wal-mart
Labeler Code49035
FDA Application Number 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.
part355
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-06-2001
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 49035-213-44

Package Description: 532 mL in 1 BOTTLE, PLASTIC

Product Details

Anticavity is a human over the counter drug product labeled by Wal-mart. The generic name of Anticavity is sodium fluoride. The product's dosage form is rinse and is administered via oral form.


What are Anticavity Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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)
  • SORBITOL (UNII: 506T60A25R)
  • MENTHOL (UNII: L7T10EIP3A)
  • METHYL SALICYLATE (UNII: LAV5U5022Y)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)


* Please review the disclaimer below.

Patient Education

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

* Please review the disclaimer below.

Anticavity Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Tep



Sealed with printed neckband for your protection

Active Ingredient



Sodium fluoride 0.05% (0.02% w/v fluoride ion)


Purpose



Anticavity rinse


Use



aids in the prevention of dental cavities


Warnings



For this product


Keep Out Of Reach Of Children



If more than used for rinsing is accidentall swallowed, seek professional assistance or contact a Poison Control Center immediately.


Diretions



  • Adults and children 6 years and older: use once a day after brushing your teeth with toothpaste
  • remove cap, pour 10 milliliters (10 mL mark on inside of cap), do not fill above 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary unitl capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Other Information



  • store at room temperature

Inactive Ingredients



water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5


Adverse Reactions



Distributed by: Wal-Mart Stores, Inc.,

Bentonville, AR 72716 Wal-Mart Stores, Inc.

213.002/213AE rev 2


Guarantee



Satisfaction guaranteed - Or we'll replace it or give you your money back.  For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915


Principal Display Panel



IMPORTANT: READ DIRECTIONS FOR PROPER USE

equate

Exclusivo

Walmart

Anticavity

Fluoride Rinse

* Please review the disclaimer below.