NDC 41250-004 Anticavity Rinse

Sodium Fluoride

NDC Product Code 41250-004

NDC CODE: 41250-004

Proprietary Name: Anticavity Rinse 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 41250 - Meijer Distribution, Inc.

NDC 41250-004-44

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Anticavity Rinse with NDC 41250-004 is a a human over the counter drug product labeled by Meijer Distribution, Inc.. The generic name of Anticavity Rinse is sodium fluoride. The product's dosage form is mouthwash and is administered via oral form.

Labeler Name: Meijer Distribution, Inc.

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.

Anticavity Rinse 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 .2 mg/mL

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.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • MEPREDNISONE DISODIUM PHOSPHATE (UNII: W80C977F6O)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SORBITOL (UNII: 506T60A25R)
  • WATER (UNII: 059QF0KO0R)

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: Meijer Distribution, Inc.
Labeler Code: 41250
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: 06-27-2002 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 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.

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.

Anticavity Rinse Product Label Images

Anticavity Rinse 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, seep 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 a toothpaste• remove cap• pour 10 milliliters (10 mL mark on inside of cap); do not fill above the 10mL 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 until capable of using without supervision• children under 6 years of age: consult a dentist or doctor

Inactive Ingredients

Benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

Other Information

•store at room temperature

Other

Sealed with printed neckband for your protection*This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse."The ADA council on Scientific Affairs Acceptance of Meijer Kids Anticavity Fluoride Rinse is based on the finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."Distributed by Meijer Distribution, Inc.Grand Rapids, MI 49544www.meijer.com

* Please review the disclaimer below.