NDC 0041-0348 Oral-b Neutra-foam Mint

Product Information

What is NDC 0041-0348?

The NDC code 0041-0348 is assigned by the FDA to the product Oral-b Neutra-foam Mint which is product labeled by Oral-b Laboratories. The product's dosage form is and is administered via form. The product is distributed in a single package with assigned NDC code 0041-0348-06 165 g in 1 bottle . 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 Code0041-0348
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.
Oral-b Neutra-foam Mint
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Oral-b Laboratories
Labeler Code0041
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.
05-04-2000
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.
12-31-2017
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".
I
NDC Code Structure

What are the uses for Oral-b Neutra-foam Mint?


Product Characteristics

Flavor(s)SPEARMINT (C73416 - SPEARMINT FLAVOR)

Product Packages

NDC Code 0041-0348-06

Package Description: 165 g in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Oral-b Neutra-foam Mint 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:

* 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.

Oral-b Neutra-foam Mint 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



Spl Patient Package Insert



NEUTRA-FOAM Foaming Solution (2.0% w/w Neutral Sodium Fluoride)FOR PROFESSIONAL USE ONLYActive Ingredient:Sodium Fluoride 2.0% w/w (0.9% or 9048 ppm fluoride ion)

Description



DESCRIPTION:Oral-B Neutra-Foam is a mint flavored neutral aqueous foaming solution of 2.0% w/w sodium fluoride.

Inactive Ingredient



Inactive Ingredients:Purified water, Poloxamer 407, Isobutane, Poloxamer 234, Spearmint flavor, Potassium phosphate, Sodium saccharin, Methylparaben, Sodium hydroxide, Propylparaben.

Clinical Pharmacology



CLINICAL PHARMACOLOGY: Sodium Fluoride inhibits caries formation by reducing enamel solubility and enhancing remineralization.

Indications & Usage



INDICATION AND USE:A topically applied foaming solution primarily suited for patients with extensive aesthetic restorations to aid in the prevention of dental caries.

Contraindications



CONTRAINDICATIONS:        • Do not use in patients with hypersensitivity to fluoride.                                            • Do not use in patients with dysphagia.

Warnings And Precautions



WARNINGS: DO NOT SWALLOW. • Accidental ingestion of the usual treatment dose (approximately 9.0 mg of fluoride) is not harmful. In the event more than the treatment dose is swallowed, administer calcium (e.g. milk) and get medical or contact a Poison control Center right away. One bottle of Neutra-Foam contains 1.43 grams of fluoride ion which could be lethal for children and adults. • Keep out of the reach of infants and children under 12 years. • Pediatric patients under 12 years of age should be supervised during use of this product. • Avoid spraying towards open flame. • Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures over 120°F (49°C).PRECAUTIONS: FOR PROFESSIONAL USE ONLY. Safety and effectiveness below age 6 have not been established. There have been no long term studies with this product to evaluate carcinogenic, mutagenic or impairment of fertility potential.

Carcinogenesis & Mutagenesis & Impairment Of Fertility



Carcinogenesis, Mutagenesis, Impairment of Fertility:
No evidence of carcinogenicity was observed in female and male mice at doses ranging from 2.4 to 18.8 mg/kg sodium fluoride of body weight (3,4). Equivocal evidence of carcinogenicity was reported in male rats at doses ranging from 2.5 to 4.1 mg/kg fluoride, but no evidence of carcinogenicity was observed in female rats (3,4). In another study, no carcinogenicity was observed in rats treated with fluoride up to 25 mg/kg of body weight (5). Overall, epidemiological studies do not show an association between fluoridated drinking water and increased cancer risk in humans (7).

Fluoride ion is not mutagenic in standard bacterial systems but has been associated with genetic aberrations in cultured human cells at doses much higher than expected for human exposure (6,8). Some in vivo studies report chromosomal aberrations in rodents while other studies using similar protocols report negative results (7).

Potential adverse reproductive effects of fluoride exposure in humans have not been adequately evaluated. Adverse reproductive effects of fluoride have been reported in animal studies, but at high concentrations sufficient to produce other manifestations of toxicity (9).



Pregnancy



Pregnancy:Teratogenic Effects: Pregnancy Category B. Fluoride readily crosses the placenta (7,9). Animal studies (rats and rabbits) have shown that fluoride is not a teratogen (10,12,13). Maternal exposure to 18 mg Fluoride/kg of body weight did not affect maternal body weight, litter size or fetal weight and did not increase frequency of skeletal or visceral malformations (10). There are no adequate and well-controlled studies in pregnant women. Several epidemiological studies show no increase in birth defects in areas with fluoridated water compared to areas with low fluoridated water (7). However, caution should be exercised when fluoride is administered to pregnant women.

Nursing Mothers



Nursing mothers: Due to the relative insensitivity of human milk fluoride levels to changes in maternal fluoride intake, and due to the very low concentrations of fluoride in human milk, fluoride supplementation during lactation would not be expected to significantly affect fluoride intake by the nursing infant (11). However, caution should be exercised when fluoride is administered to nursing women.

Pediatric Use



Pediatric use: The use of fluoride solutions, gels, and foams containing up to 1.23 % fluoride ion as caries preventives in pediatric patients aged 6 to 16 years is supported by clinical studies in students aged 6 to 12 years (1,2). Safety and effectiveness in pediatric patients below the age of 6 years has not been established. Please refer to CONTRAINDICATIONS and WARNINGS sections.

Geriatric Use



Geriatric use: No overall differences in safety or effectiveness have been observed between geriatric and younger patients. This drug is known to be substantially excreted by the kidney, therefore the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


Adverse Reactions



ADVERSE REACTIONS: Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache and weakness. In patients with mucositis, gingival tissues may be hypersensitive to the flavor.


Overdosage



OVERDOSAGE: Accidental ingestion of large amounts of fluoride can result in acute irritation of the mouth and gastrointestinal tract as well as the development of gastrointestinal symptoms such as nausea, vomiting, diarrhea, hematemesis epigastric cramping and abdominal pain. If a large amount of fluoride equal to or greater than 5 mg fluoride/kg body weight (2.3 mg fluoride/lb body weight) is ingested, give calcium (e.g. milk, 5% calcium gluconate or calcium solution) orally to relieve gastrointestinal symptoms and admit immediately to a hospital facility. A standard treatment dose of Neutra-Foam contains approximately 9.0mg fluoride. One 165 g (5.8 oz) bottle contains approximately 1.43 g of fluoride.

Dosage & Administration



DOSAGE AND ADMINISTRATION: Adults and Children 6 years and over: Use foam 2 times a year. The initial time you dispense from a new bottle, gently lift upward on the nozzle to break the protective seal (thin plastic tab located adjacent to trigger). If this seal is broken do not use product. When breaking this seal, there could be an initial surge of foam from the dispenser.• Shake bottle vigorously for 3-4 seconds prior to dispensing.• Invert bottle 180° with nozzle tip pointed downward into tray.• Place nozzle tip close to the tray floor and at one end of the tray arch. Moving from one end of the tray to the other in one fluid motion, slowly press down on the trigger. (Note: foam will expand slightly to fill the tray.)• Do not use excessive finger pressure which could result in too much foam being dispensed.• Immediately place tray(s) in mouth. (Note: Do not fill trays with foam too far in advance of treatment as the foam will collapse and not be as effective.)• Have patient bite down on the tray(s) lightly but firmly for up to 4 minutes.• Remove tray(s) and have patient expectorate.• Instruct patient not to eat, drink, or rinse for at least 30 minutes. For optimal tooth coverage, use a fluoride applicator tray which is deep enough to reach the entire vertical height of all teeth (even the molars). You can choose from single arch trays (such as CENTRAYS) or dual arch trays (CENTWINS or SOFTWINS).

How Supplied



HOW SUPPLIED: Neutra-Foam is available in a 5.8 oz (165 g) plastic aerosol container in mint flavor. NDC 0041-0348-06.

References



REFERENCES:
(1.) Wellock, W.D. and Brudevold, F.: Arch. Oral Biol., 10, 453-460 (1965) (2.) Jiang, H et al.: J. Dent, 33, 469-473 (2005) (3.) National Toxicology Program: NTP TR 393, NIH Publication 91-2842, (1990) (4.) Bucker, J.R. et al.: Int. J. Cancer 48, 733-737 (1991) (5.) Maurer, J.K. et al.: J. Natl. Cancer Inst. 82, 1118-1126 (1990) (6) Martin, G.R. et al.: Mutat. Res. 66, 159-167 (1979) (7.) Agency for Toxic Substances and Disease Registry: Toxicological Profile for Fluoride (2003)
(8.) Aardema, M.J. et al.: Mutat. Res. 331 (1), 171-172 (9.) National Research Council: Fluoride in Drinking Water (2006) (10.) Heindel, J.J. et al.: Fundam Appl Toxicol, 30, 162-177 (1996) (11.) Institute of Medicine, Food and Nutrition Board: Dietary Reference Intakes (1997) (12.) Collins, T.F. et al.: Food Chem. Toxicol. 33 (11), 951-960 (13.) Collins, T.F. et al.: Food Chem Toxicol. 39 (8), 867-876


Package Label.Principal Display Panel



Minute Foam Label 


* Please review the disclaimer below.