NDC 41167-0968 Act Total Care Dry Mouth Anticavity Mouth
Sodium Fluoride Rinse Topical

Product Information

Product Code41167-0968
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.
Act Total Care Dry Mouth Anticavity Mouth
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.
  • 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.
Chattem, Inc.
Labeler Code41167
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.
02-01-2011
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 Characteristics

Flavor(s)MINT (C73404)

Product Packages

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 41167-0968-9

Package Description: 30 mL in 1 BOTTLE

Product Details

Act Total Care Dry Mouth Anticavity Mouth is 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.


What are Act Total Care Dry Mouth Anticavity Mouth 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 indicates multiple concept unique identifiers (RXCUIs) are 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)
  • 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)


* 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.

Act Total Care Dry Mouth Anticavity Mouth 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



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 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 until capable of using without supervision
  • children 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


Principal Display Panel



#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
® TOTAL CARE
ANTICAVITY FLUORIDE RINSE
DRY MOUTH
 SOOTHES Dry Mouth
 MOISTURIZES Mouth Tissue
 STRENGTHENS Teeth
 FRESHENS Breath
Sodium Fluoride 0.02%
18 fl oz (532 mL)


* Please review the disclaimer below.