NDC 11673-213 Fluoride Mouth Rinse Anticavity

Sodium Fluoride

NDC Product Code 11673-213

NDC 11673-213-44

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Fluoride Mouth Rinse Anticavity with NDC 11673-213 is a 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 RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 240698.

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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.

Fluoride Mouth Rinse 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)
  • 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)

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: Target Corp.
Labeler Code: 11673
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: 08-17-2010 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.

Information for Patients

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.

Fluoride Mouth Rinse Anticavity Product Label Images

Fluoride Mouth Rinse 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 0.05% (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 toothpasteremove cappour 10 milliliters (10 mL mark on inside of cap); do not fill above the 10 mL markvigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit it 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 childrenas necessary until capable of using without supervisionchildren 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 ActDist. by Target Corp., Mpls., MN 55403Made in U.S.A. with U.S. and foretign componentsShop Target.comGuest Services 1-800-910-6874213.002/213AE rev 2

* Please review the disclaimer below.