NDC 41167-0968 Act Total Care Dry Mouth Anticavity Mouth

Sodium Fluoride

NDC Product Code 41167-0968

NDC CODE: 41167-0968

Proprietary Name: Act Total Care Dry Mouth Anticavity Mouth 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.

Product Characteristics

Flavor(s):
MINT (C73404)

NDC Code Structure

NDC 41167-0968-0

Package Description: 532 mL in 1 BOTTLE

NDC 41167-0968-3

Package Description: 1000 mL in 1 BOTTLE

NDC 41167-0968-5

Package Description: 88 mL in 1 BOTTLE

NDC Product Information

Act Total Care Dry Mouth Anticavity Mouth with NDC 41167-0968 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Act Total Care Dry Mouth Anticavity Mouth is sodium fluoride. The product's dosage form is rinse and is administered via topical form.

Labeler Name: Chattem, Inc.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

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.

Act Total Care Dry Mouth Anticavity Mouth 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 .09 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITOL (UNII: 506T60A25R)
  • XYLITOL (UNII: VCQ006KQ1E)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • BETAINE (UNII: 3SCV180C9W)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • CARNOSINE (UNII: 8HO6PVN24W)
  • GINGER (UNII: C5529G5JPQ)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • PUERARIA MONTANA VAR. CHINENSIS ROOT (UNII: FQN0D1U235)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)
  • CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Chattem, Inc.
Labeler Code: 41167
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: 02-01-2011 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: 12-31-2021 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".

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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]

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Act Total Care Dry Mouth Anticavity Mouth 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% (0.009% w/v fluoride ion)

Purpose

Anticavity

Use

  • Aids in the prevention of dental cavities

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 a day after brushing your teeth with a toothpasteremove cappour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL markvigorously swish 10 milliliters 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

Other Information

  • Do not use if safety seal is broken or missing

Inactive Ingredients

Water, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, flavors, bisabolol, carnosine, PEG-14M, PEG-160M, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (309-043)Learn more at www.ACTFLUORIDE.com

* Please review the disclaimer below.