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Drugs and Health Products

Oral Health Products

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product (NHP) market authorization. It is not intended to be a comprehensive review of the medicinal ingredients.

Notes
  • Text in parentheses is additional optional information which can be included on the PLA and product label at the applicant's discretion.
  • The solidus (/) indicates that the terms and/or the statements are synonymous. Either term or statement may be selected by the applicant.

Date

December 16, 2014

Proper name(s), common name(s), source material(s)

Table 1: Proper name(s), common name(s), source material(s)
Proper name(s) Common name(s) Source material(s)

Table 1 Footnotes

Table 1 Footnote 1

Acidulated phosphate fluoride is derived from sodium fluoride acidulated with a mixture of sodium phosphate, dibasic or monobasic and phosphoric acid to a level of 0.1 molar phosphate to yield a pH of 3.0 to 4.5 (FDA 1995).

Return to Table 1 footnote1 referrer

Table 1 Footnote 2

Ingredient must be pharmacopoeial grade (see Specifications section)

Return to Table 1 footnote* referrer

Table 1 Footnote 3

The CAS number may be provided as additional information.

Return to Table 1 footnote+ referrer

Acidulated phosphate fluoride1
(USP 32)
Acidulated phosphate fluoride
(USP 32)
Acidulated phosphate fluoride*
(USP 32)
Nitric acid potassium salt (1:1)
(Merck 2012; USP 34;
Gottschalck and Bailey 2008)
Potassium nitrate
(Merck 2012; USP 34;
Gottschalck and Bailey 2008)
Potassium nitrate*
(Merck 2012;USP 34; Gottschalck and Bailey 2008)
Sodium fluoride
(Merck 2012;USP 32; Gottschalck and McEwen 2006)
Sodium fluoride
(Merck 2012;USP 32; Gottschalck and McEwen 2006)
Sodium fluoride* 
(Merck 2012;USP 32; Gottschalck and McEwen 2006)
CAS No. 7681-49-4+
Sodium monofluorophosphate
(USP 32; Gottschalck and McEwen 2006)
Sodium monofluorophosphate
(USP 32; Gottschalck and McEwen 2006)
Sodium monofluorophosphate*
(USP 32; Gottschalck and McEwen 2006)
CAS No. 10163-15-2+
Phosphorofluoridic acid, disodium salt
(USP 32)
Disodium phosphorofluoridate
(USP 32)
Stannous fluoride
(Merck 2012;USP 32; Gottschalck and McEwen 2006)
Stannous fluoride
(Merck 2012;USP 32; Gottschalck and McEwen 2006)
Stannous fluoride*
(Merck 2012;USP 32; Gottschalck and McEwen 2006)
CAS No. 7783-47-3+
Tin (II)-fluoride
(Merck 2012;USP 32)
Tin fluoride
(Merck 2012)
Tin difluoride
(Merck 2012)
Tin difluoride
(Merck 2012)

Route(s) of administration

Dental

Dosage form(s)

Products containing Potassium nitrate

Dentifrice paste (Toothpaste), dentifrice gel, treatment rinse, concentrated treatment, rinse (solution, effervescent tablet, or powder), mouthwash (rinse)

All other Products

Dentifrice paste (toothpaste), dentifrice gel, preventive treatment gel, treatment rinse, concentrated treatment rinse (solution, effervescent tablet, or powder),mouthwash (rinse) (FDA 1995)

Note: Refer to Appendix 1 for definitions.

Use(s) or Purpose(s)

Statement(s) to the effect of
Products containing Potassium nitrate
  • Helps reduce (painful) sensitivity of the teeth to cold, heat, acids, sweets, or contact (Silverman et al. 1996; Nagata et al. 1994; FDA 1991).
  • Builds protection against (painful) sensitivity of the teeth to cold, heat, acids, sweets, or contact (Palé et al. 2013; FDA 1991).
  • Effective protection against (painful) sensitivity of the teeth to cold, heat, acids, sweets, or contact (Palé et al. 2013; FDA 1991).
  • Shields/soothes dental nerves for lasting sensitivity relief when used regularly (Silverman et al. 1996; Nagata et al. 1994; FDA 1991).
All other Products
  • Anti-cavity/anti-caries (IOM 1997; Zimmerman 1992)
  • Prevents, fights and/or protects against cavities or caries(Sweetman 2007; FDA 1995; Zimmerman 1992).
  • Reduces the incidence of cavities/caries(Sweetman 2007; FDA 1995; Zimmerman 1992).
  • Helps prevent tooth decay(Sweetman 2007; FDA 1995; Zimmerman 1992).
  • Effective fluoride protection(FDA 1995).
  • Effective decay preventive fluoride(FDA 1995).
  • Helps reverse the tooth decay process at the earliest stage before it can become a cavity (IOM 1997).
  • Penetrates tooth enamel to help rebuild weak spots(Sweetman 2007; Zimmerman 1992).
  • Helps remineralize tooth enamel(Sweetman 2007; Zimmerman 1992).
  • Protects teeth from acid wear/erosion (Sweetman 2007; IOM 1997; Zimmerman 1992).
Note:
  • Product labels must contain at least one of the above use(s) or purpose(s).
  • Claims that are cosmetic in nature such as "whitens teeth" or "refreshes mouth" are acceptable as additional information, provided that these claims are true and verifiable.

Dose(s)

Subpopulation(s)

Dentifrice products that do not contain Potassium nitrate

Adults and children 2 years of age and older (FDA 1995)

Products that do not contain Potassium nitrate in the following dosage forms: Preventive treatment gel; treatment rinse; concentrated treatment rinse, mouthwash (rinse)

Adults and children 6 years of age and older (FDA 1995)

Products containing Potassium nitrate

Adults and children 12 years of age and older(FDA 1991)

Quantity(ies)

Note:
  • Quantity (%) is required on the Product Licence Application (PLA) and product label.
  • For fluoride containing products, Theoretical Total Fluoride and Available Fluoride Ion are both required on the PLA and may be included on the product label as additional optional information.
Table 2: Dose information for dentifrice (gel or (tooth)paste)*
Medicinal ingredient Quantity
(% w/w)
Theoretical
Total Fluoride
(mg/kg1)
Available Fluoride Ion
(mg/kg1)
Frequency

Table 2 Footnotes

Table 2 Footnote 1

Based on FDA 1995

Return to Table 2 footnote* referrer

Table 2 Footnote 2

mg/kg = ppm

Return to Table 2 footnote1 referrer

Table 2 Footnote 3

PO3F2- and F- combined

Return to Table 2 footnote2 referrer

Table 2 Footnote 4

For products containing abrasives other than calcium pyrophosphate

Return to Table 2 footnote3 referrer

Table 2 Footnote 5

For products containing the abrasive calcium pyrophosphate

Return to Table 2 footnote4 referrer

Table 2 Footnote 6

Note: End of Shelf life minimal fluoride Ion values in mg/kg can be included as additional information on the label but are not required on the PLA. These values are intended for determining expiration dating and are not to be used for determining safety and efficacy. See Appendix 2.

Potassium nitrate 5 N/A N/A Minimum twice a day
Sodium fluoride 0.188 - 0.254 850 - 1150 ≥ 650 Minimum twice a day
Sodium monofluorophosphate 0.654 - 0.884 850 - 1150 ≥ 800 2 Minimum twice a day
Stannous fluoride 0.351 - 0.474 850 - 1150 ≥ 700 3 Minimum twice a day
0.351 - 0.474 ≥ 290 4


Table 3: Dose information for preventive treatment gel, treatment rinse and concentrated treatment rinse (solution, effervescent tablet, or powder), mouthwash (rinse)*
Medicinal ingredient Quantity
(% w/w)
Frequency

Table 3 Footnotes

Table 3 Footnote *

Based on Sharma et al. 2012, Sweetman 2007, Gillam 1996, FDA 1995.

Return to Table 3 footnote* referrer

Table 3 Footnote 1

For concentrated treatment rinse products requiring dilution: The labels must contain the quantity of the product before and after dilution as well as the appropriate dilution directions.

Return to Table 3 footnote1 referrer

Table 3 Footnote 2

In preventive treatment gel form only

Return to Table 3 footnote2 referrer

Potassium Nitrate 3 Twice a day
Sodium Fluoride 0.02 Twice a day
0.05 Once a day
0.2* Once a week
Concentrated treatment rinse1 Diluted in water to 0.02 Twice a day
Diluted in water to 0.05 Once a day
Diluted in water to 0.2* Once a week
Acidulated phosphate fluoride 0.01 Twice a day
0.02 Once a day
Stannous fluoride 0.42 Once a day
Concentrated treatment rinse1 Diluted in water to 0.1 Once a day

Permitted combinations

  • Potassium nitrate can be combined with any one of the ingredient indicated in Table 2 or Table 3.
  • Other combinations must be assessed through the non-compendial stream of the Natural and Non-Prescription Health Products Directorate (NNHPD).

Directions for use

Statement(s) to the effect of
All products
  • Do not swallow (FDA 1995).
  • Optional: Should be used as part of an oral health program that includes regular flossing and dental check-ups (CDA 2014).
Dentifrice products

Brush teeth thoroughly (for at least 1 minute), preferably after each meal, or as directed by a health care practitioner (FDA 1995).

Dentifrice products that do not contain Potassium nitrate
  • Children under 6 years of age should use only a pea-sized amount and be supervised to brush properly and to not swallow (CDA 2014).
  • Optional: Consult a health care practitioner before using in children under 2 years of age (FDA 1995).
Preventive treatment gels; treatment rinses; concentrated treatments, mouthwash (rinse) products
  • Use after brushing teeth with toothpaste (Smith 2002; FDA 1995).
  • Do not eat, drink or rinse with water for 30 minutes after use (Smith 2002; FDA 1995).
  • Instruct children under 12 years of age in the proper use of the product and in good brushing and rinsing habits to minimize swallowing (Smith 2002; FDA 1995).
  • Weekly rinses with 0.2% sodium fluoride: Not recommended for use in children under 6 years of age (Sweetman 2007).
  • Daily rinses with 0.02% and 0.05% sodium fluoride (optional): Consult a health care practitioner before using in children under 6 years of age (Smith 2002; FDA 1995).
  • Products containing potassium nitrate: Not recommended for children under 12 years of age (FDA 1995).
Preventive treatment gel products

Apply the gel to teeth and brush thoroughly. Allow the gel to remain on the teeth for 1 minute and then spit out (Smith 2002; FDA 1995).

Treatment rinses; concentrated treatment rinses (after proper dilution), mouthwash (rinse) products

Swish approximately 10 ml of rinse vigorously around and between the teeth for 1 minute and then spit out (Smith 2002; FDA 1995).

Concentrated treatment rinse products in a solution; effervescent tablet; powder dosage form
  • Do not use before mixing with water and/or until all the tablet/powder has dissolved completely (FDA 1995).
  • Use immediately after preparing the rinse (FDA 1995).

Duration of use

No statement required.

Risk information

Statement(s) to the effect of

Caution(s) and warning(s)

Dentifrice products that do not contain Potassium nitrate
  • Keep out of reach of children under 6 years of age.
  • If a quantity greater than the dose used for brushing is accidentally swallowed, get medical help or contact a Poison Control Centre right away (FDA 1995).
Products containing Potassium nitrate
  • If symptoms persist or worsen, consult a dentist (FDA 1991).
  • Keep out of reach of children.
Preventive treatment gels; treatment rinses; concentrated treatment rinses, mouthwash (rinse) products
  • Keep out of reach of children.
  • If a quantity greater than the dose used for brushing and/or rinsing is accidentally swallowed, get medical help or contact a Poison Control Centre right away (FDA 1995).
Preventive treatment gels containing stannous fluoride

This product may produce surface staining of the teeth. Adequate brushing may prevent these stains which are harmless and temporary and may be removed by a dental care practitioner (FDA 1995).

Products containing more than the equivalent of 120 mg of fluoride ion, except those in toothpaste form (includes dentifrice paste and dentifrice gel)

Keep out of the reach of children. This product contains enough fluoride to seriously harm a child. (Note: These cautionary statements shall be preceded by a prominently displayed symbol that is octagonal in shape, conspicuous in colour and on a background of a contrasting colour. If the product is recommended solely for children, all package sizes must be packaged in a child-resistant package (CRP). If the product is not recommended solely for children, at least one of the sizes of packages available for sale must be packaged in CRP and all other package sizes must carry a statement that the NHP is available in a CRP, as per Section 97 of the Natural Health Product Regulations, citing Sections C.01.029, C.01.031 and C.01.031.2 (1) of the Food and Drug Regulations (JC 2014)).

Contraindication(s)

No statement required.

Known adverse reaction(s)

No statement required.

Non-medicinal ingredients

  • The International Nomenclature for Cosmetic Ingredients (INCI) is acceptable.
  • Non medicinal ingredients must be chosen from the current NNHPD Natural Health Products Ingredients Database (NHPID) and must meet the limitations outlined in the database.
  • Other ingredients currently accepted as cosmetic ingredients will also be considered. 

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD "Quality of Natural Health Products Guide.".
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredients Database (NHPID).
  • The medicinal ingredient must either:
    1. Comply with the specifications outlined in the monographs published in the British(BP), European (Ph. Eur.) or United States(USP) pharmacopoeias (Table 4 below); or,
    2. Be cited in an approved NHP Master File, authorized by a letter of access issued to the applicant by the NHP Master File's registered owner.
  • This monograph describes those requirements that are specific to this class of natural health products (NHPs). Any change to the manufacturing process that impacts the safety and efficacy of the ingredients, such as the use of novel technology (e.g. nanotechnology), requires supporting data and will be reviewed outside the monograph.
  • Diethylene glycol (DEG) is not acceptable as a non-medicinal ingredient. Product licence applicants must have a copy of a Certificate of Analysis or any other equivalent document confirming the absence of DEG in the finished product on file. This information is not to be submitted with the compendial Product Licence Application, although it may be requested at the NHPD's discretion.
  • Products containing glycerin as a non-medicinal ingredient must meet the specifications as outlined in the United States Pharmacopoeia.
Table 4: Monographs published in the British Pharmacopoeia (BP), European Pharmacopoeia (Ph. Eur.) and the U.S. Pharmacopoeia (USP)
Pharmacopeia Monograph
BP
Ph. Eur.
Sodium Fluoride
Potassium Nitrate
USP Sodium Fluoride
Sodium Fluoride Oral Solution
Sodium Fluoride Tablets
Sodium Fluoride and Phosphoric Acid Gel
Sodium Monofluorophosphate
Stannous Fluoride
Stannous Fluoride Gel
Potassium Nitrate

References cited

  • CDA 2014: Canadian Dental Association. Next link will take you to another Web site 5 Steps to Good Oral Health [Internet]. Ottawa (ON): Canadian Dental Association. [Accessed 2014 February 24].
  • FDA 1995: United States Food and Drug Administration. Next link will take you to another Web site Anticaries Drug Products for Over-the-Counter Human Use; Final Monograph [Internet]. Code of Federal Regulations Title 21, Parts 310, 355, and 369, Docket No. 80N-0042, RIN 0910-AA01. Rockville (MD): United States Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2014 February 16].
  • FDA 1991: United States Food and Drug Administration. Next link will take you to another Web site Oral Health Care Drug Products for Over-the-Counter Human Use; Amendment to Tentative Final Monograph to Include OTC Relief of Oral Discomfort Drug Products [Internet]. 21 CFR Parts 356 and 369. Docket No. 81N-0033. RIN 0905-AA06. Rockville (MD): United States Department of Health and Human Services, U.S. food and Drug Administration. [Accessed 2014 February 16].
  • Gillam DG, Bulman JS, Jackson RJ, Newman HN. Efficacy of a potassium nitrate mouthwash in alleviating cervical dentine sensitivity. Journal Of Clinical Periodontology 1996; 23:993-997
  • Gottschalck TE, McEwen GN, editors.International Cosmetic Ingredient Dictionary and Handbook, 11th edition. Washington (DC): Cosmetic, Toiletry and Fragrance Association;2006.
  • IOM 1997: Institute of Medicine. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Washington (DC): National Academy Press;1997
  • JC 2014: Department of Justice Canada. Next link will take you to another Web site Food and Drug Regulations. Sections C.01.029, C.01.031 and C.01.031.2 (1). Cautionary Statements and Child Resistant Packages. [internet]. Ottawa (ON): Department of Justice Canada. [Regulations are current to 2014-02-06; Last amended on 2008-06-01; Accessed 2014 February 22].
  • Merck 2012: Next link will take you to another Web site The Merck Index Version 14.1. MedicinesComplete - Merck. Whitehouse Station (NJ): Merck & Co., Inc. Copyright © 2006, 2012 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. [Published 2006; Updated 2012; Accessed 2014 November 25].
  • Nagata T, Ishida H, Shinohara H, Nishikawa S, Kasahara S, Wakano Y, Daigen S, Troullos ES. Clinical evaluation of potassium nitrate dentifrice for the treatment of dentinal hypersensitivity. Journal of Clinical Periodontology 1994;21(3):217-221.
  • Palé M, Mayoral JR, Llopis J, Vallès M, Baislio J, Roig M. Evaluation of the effectiveness of an in-office bleaching system and the effect of potassium nitrate as a desensitizing agent Odontology:-2013102:203-210.
  • Sharma S, Shetty NJ, Uppoor A. Evaluation of the clinical efficacy of potassium nitrate desensitizing mouthwash and a toothpaste in the treatment of dentinal hypersensitivity. Journal of Clinical and Experimental Dentistry 2012;4(1):e28-e33
  • Silverman G, Berman E, Hanna CB, Salvato A, Fratarcangerlo P, Bartizek RD, Bollmer BW, Campbell SL, Lanzalaco AC, Mackay BJ, McClanahan SF, Perlich MA, Shaffer JB. Next link will take you to another Web site Assessing the efficacy of three dentifrices in the treatment of dentinal hypersensitivity [Internet]. The Journal of the American Dental Association 1996;127(2):191-201. [Accessed 2014 February 24].
  • Smith RG. Prevention of hygiene-related oral disorders. In: Berardi RR, DeSimone II EM, Newton GD, Oszko MA, Popovich NG, Rollins CJ, Shimp LA, Tietze KJ, editors. Handbook of Nonprescription Drugs: An Interactive Approach to Self-care, 13th edition. Washington (DC): American Pharmaceutical Association;2002.
  • Sweetman SC, editor. Martindale: The Complete Drug Reference, 35th edition. London (GB): Pharmaceutical Press;2007.
  • USP 32: United States Pharmacopeial Convention. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention;2009.
  • Zimmerman DR. Zimmerman's Complete Guide to Nonprescription Drugs, 2nd edition.  Detroit (MI): Gale Research Inc;1992.

References reviewed

  • American Dental Association. Dental Product Spotlight: Topical fluoride. Journal of the American Dental Association 2002;133(4):502-503.
  • Barnhart WE, Hiller LK, Leonard GJ, Michaels SE. Dentifrice usage and ingestion among four age groups. Journal of Dental Research 1974;53(6):1317-1322.
  • BP 2007: British Pharmacopoeia Commission. British Pharmacopoeia 2008, Volume 1. London (GB): The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), 2007.
  • Bremmer HJ, Prud'homme de Lodder LCH, van Engelen JGM. 2006. Next link will take you to another Web site Cosmetics Fact Sheet: To assess the risk for the consumer. Updated version for ConsExpo 4. RIVM report 320104001/2006 [Internet]. Bilthoven (NL): National Institute for Public Health and the Environment. [Accessed 2014 November 25].
  • Brun R. Recurrent benign apathous stomatitis and fluoride allergy. Dermatology 2004;208(2):181.
  • Camarasa JG, Serra-Baldrich E, Lluch M, Malet A. Contact urticaria from sodium fluoride. Contact Dermatitis 1993;28(5):294.
  • Canadian Dental Association. 2005. Next link will take you to another Web site Your Oral Health: Flossing ; Brushing [Internet]. Ottawa (ON): Canadian Dental Association. [Accessed 2009 February 16].
  • Canadian Dental Association. 2005. Next link will take you to another Web site Your Oral Health: Cleaning Teeth [Internet]. Ottawa (ON): Canadian Dental Association. [Accessed 2009 April 08].
  • Canadian Dental Association/National Post. 2005. A Joint Venture Supplement of the Canadian Dental Association with the National Post: Oral Health. 2005. The National Post. 2005 April 4. JV1-JV15.
  • Canadian Dental Association 2012. Next link will take you to another Web siteCDA Position on Use of Fluorides in Caries Prevention [Internet]. Ottawa (ON): Canadian Dental Association. [March 2003; Revised: March 2012; Accessed 2014 February 24].
  • Ciancio SG. Dental Products. In: Swarbrick J, editor. Encyclopedia of Pharmaceutical Technology, 3rd edition. New York (NY): Informa Healthcare;2007.
  • Food and Drug Administration 1980: United States Food and Drug Administration. Next link will take you to another Web siteAnticaries Drug Products for Over-the-Counter Human Use Establishment of a Monograph; Notice of Proposed Rulemaking [Internet]. Federal Register, Volume 45, Number 62, March 28, 1980, Proposed Rule  Docket Number 80N-0042. Rockville (MD): U. S. Department of Health and Human Services, Food and Drug Administration. [Accessed 2009 February 16].
  • Hashizume LN, Lima YB, Kawaguchi Y, Cury JA. Fluoride availability and stability of Japanese dentifrices. Journal of Oral Science 2003;45(4):193-199.
  • Hattab FN. Analytical methods for the determination of various forms of fluoride in toothpastes. Journal of Dentistry 1989;17(2):77-83.
  • Health Canada 2006: Health Canada. Health Canada Guidance to Industry: Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices [Internet]. Ottawa (ON): Device Licensing Services Division, Medical Devices Bureau, Health Canada. [Accessed 2009 February 16].
  • Hujoel PP, Cunha-Cruz J, Banting DW, Loesche WJ. Dental flossing and interproximal caries: a systemic review. Journal of Dental Research 2005;85(4):298-305.
  • Next link will take you to another Web site International Programme on Chemical Safety, PCS 1984. Environmental Health Criteria 36. Fluorine and Fluorides [Internet]. Geneva (CH): World Health Organization. [Accessed 2009 February 16].
  • Next link will take you to another Web site International Programme on Chemical Safety, PCS 2002. Environmental Health Criteria 227. Fluorides [online]. Geneva (CH): World Health Organization. [Accessed 2009 February 16].
  • Keanie H. Fluoride allergy. British Dental Journal 2007;202(9):507-508.
  • Medicines and Healthcare Products Regulatory Agency. 2006. Next link will take you to another Web site  list of substances which are present in prescription only medicines (POM), with exemptions for Pharmacy sale or supply (P) [Internet]. London (GB): Medicines and Healthcare Products Regulatory Agency. [Accessed 2009 February 16].
  • Medicines and Healthcare Products Regulatory Agency. 2007. Next link will take you to another Web site A Guide to What Is A Medicinal Product [Internet]. London (GB): Medicines and Healthcare Products Regulatory Agency. [Accessed 2009 April 08].
  • Mummery RV. Claimed fluoride allergy. British Dental Journal 1984;157(2):48.
  • Pereira R, Chava VK. Efficacy of a 3% Potassium Nitrate Desensitizing Mouthwash in the Treatment of Dentinal Hypersensitivity. J Periodontol. 2001 Dec;72(12):1720-5.
  • Ph. Eur. 2008: European Pharmacopoeia Commission. European Pharmacopoeia, 6th edition, Volume 1. Strasbourg (FR): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM); 2008.
  • Särner B, Lingström P, Birkhed D. Fluoride release from NaF- and AmF-impregnated toothpicks and dental flosses in vitro and in vivo. Acta Odontologica Scandinavica 2003;61(5):289-296.
  • Stephen KW. Fluoride toothpastes, rinses and tablets. Advances in Dental Research 1994;8(2):185-189.
  • Zero DT. Dentifrices, mouthwashes, and remineralization/caries arrestment strategies.  BMC Oral Health 2006;6(Suppl 1):S9.

Appendix 1

Definitions

Dentifrice
An abrasive-containing dosage form (gel or paste) for delivering a medicinal agent to the teeth (FDA 1995), e.g. toothpaste.
Mouthwash
An aqueous solution of one or more active ingredients intended, usually after dilution with warm water, for use in contact with the mucous membranes of the oral cavity, including gargling. Most often used for its deodorant, refreshing, or antiseptic effect.
Preventive treatment gel
A dosage form for delivering a medicinal agent to the teeth. Preventive treatment gels are formulated in an anhydrous glycerine base with suitable thickening agents included to adjust viscosity. Preventive treatment gels do not contain abrasives (FDA 1995).
Treatment rinse
A liquid dosage form for delivering a medicinal agent to the teeth (FDA 1995).
Treatment rinse concentrated solution
A fluoride treatment rinse in a concentrated form to be mixed with water before using to result in the appropriate fluoride concentration specified in the monograph (FDA 1995).
Treatment rinse effervescent tablets
A fluoride treatment rinse prepared by adding an effervescent tablet (a concentrated solid dosage form) to water before using to result in the appropriate fluoride concentration specified in the monograph (FDA 1995).
Treatment rinse powder
A fluoride treatment rinse prepared by adding the powder (a concentrated solid dosage form) to water before using to result in the appropriate fluoride concentration specified in the monograph (FDA 1995).

Appendix 2

Medicinal ingredient End-of-Shelf Life Minimal Fluoride Ion (mg/kg1)

Table 1 Footnotes

Table 5 Footnote 1

mg/kg = ppm

Return to Table 5 footnote1 referrer

Table 5 Footnote 2

For products containing abrasives other than calcium pyrophosphate

Return to Table 5 footnote 2 referrer

Table 5 Footnote 3

For products containing the abrasive calcium pyrophosphate

Return to Table 5 footnote 3 referrer

Potassium nitrate N/A
Sodium fluoride ≥ 403
Sodium monofluorophosphate ≥ 600
Stannous fluoride ≥ 650 2
≥ 1083 3