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ADA Seal Product Report

Sheffield Fluoride Toothpaste NS#3415 (Original, Bubblegum, Mint Flavors)

Sheffield Pharmaceuticals
ADA Seal Statement 
"The ADA Council on Scientific Affairs’ Acceptance of Sheffield Fluoride Toothpaste NS#3415 (Original, Bubblegum, Mint Flavors) is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed."
Basis for Acceptance 
A company earns the ADA Seal for its product by providing evidence that meets the ADA criteria for safety and efficacy.  The ADA Council on Scientific Affairs carefully evaluates the evidence according to the Guidelines for Participation in the ADA’s Seal of Acceptance Program.  In addition, there is a specific guideline for this product category called Fluoride-Containing Dentifrices which includes, but is not limited to, the following criteria:
  • Total fluoride
  • Available fluoride in fresh & aged samples
  • One minute fluoride release rate in fresh & aged samples
  • Bioavailability in demineralized enamel
  • Must meet ISO 11609 Dentistry Toothpaste Requirements Tests Methods and Making
  • Effect on oral soft tissue
  • Effect on oral hard tissues
  • Effect on dental restorations
  • Toxicological information about ingredients
Brief Description of Product, Indications and Directions for Use 
  • Fluoride Toothpaste.
  • Helps protect against cavities.
  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
  • Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Only use a pea size amount.
  • Supervise children as necessary until capable of using without supervision.
  • Children under 2 years: consult a dentist or doctor.
Ingredients 
Active Ingredients:
Sodium fluoride [0.15% w/v Fluoride Ion] for anticavity

Inactive Ingredients:
Sorbitol, water, hydrated silica, glycerin, sodium lauryl sulfate, PEG 6, cellulose gum, flavor, disodium phosphate, sodium saccharin, titanium dioxide, FD&C Blue No. 1
Label Warnings 
Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact Poison Control Center right away.
Company Information 
Additional information about the product, including whether coupons or promotions are available, is available on the company's web site.
Sheffield Pharmaceuticals 170 Broad St. New London, CT 06320 Ph: 860 442 4451 Ph: 800 222 1087 http://www.sheffield-pharmaceuticals.com/