NDC 11673-213 Fluoride Mouth Rinse Anticavity
Sodium Fluoride Mouthwash Oral

Product Information

What is NDC 11673-213?

The NDC code 11673-213 is assigned by the FDA to the product Fluoride Mouth Rinse Anticavity which is a human over the counter drug product labeled by Target Corp.. The generic name of Fluoride Mouth Rinse Anticavity is sodium fluoride. The product's dosage form is mouthwash and is administered via oral form. The product is distributed in a single package with assigned NDC code 11673-213-44 532 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code11673-213
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.
Fluoride Mouth Rinse 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 FormMouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
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.
Target Corp.
Labeler Code11673
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.
08-17-2010
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

What are the uses for Fluoride Mouth Rinse Anticavity?


Product Packages

NDC Code 11673-213-44

Package Description: 532 mL in 1 BOTTLE, PLASTIC

Product Details

What are Fluoride Mouth Rinse Anticavity Active Ingredients?

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.

Fluoride Mouth Rinse Anticavity Active Ingredients UNII Codes

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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Fluoride Mouth Rinse Anticavity Inactive Ingredients UNII Codes

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.

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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]

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Fluoride Mouth Rinse Anticavity Product Label

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.

Product Label Table of Contents



Active Ingredient



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


Purpose



Anticavity rinse


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, seek professional assistance or contact a Poison Control Center immediately.


Directions



  • adults and children 6 years of age 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 the 10 mL mark
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit it 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 childrenas necessary until 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


Other



The ADA Council on Scientific Affairs Acceptance of up & up mint anticativity fluoride rinse is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act

Dist. by Target Corp., Mpls., MN 55403

Made in U.S.A. with U.S. and foretign components

Shop Target.com

Guest Services 1-800-910-6874

213.002/213AE rev 2


Principal Display Panel



SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ANTICAVITY

fluoride mouthrinse

*Compare to Act Anticavity Fluoride Rinse

helps prevent cavities

helps strengthen teeth

freshens breath

up & up

Mint Flavor

IMPORTANT: read directions for proper use

18 fl oz (532 mL)


* Please review the disclaimer below.