NDC | 55319-900-01 |
Set ID | 22b5d423-b43a-4be9-be98-998640ff1c13 |
Category | HUMAN OTC DRUG LABEL |
Packager | Family Wellness |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART356 |
- Active Ingredients
- USES
- Purpose
- WARNINGS
- Keep out of reach of children
-
Directions
Adults and children 12 years and older Brush teeth for at least one minute, preferably after each meal, or at least twice a day or as directed by your dentist. Be sure to brush sensitive areas of the teeth.
Children under 12 years of age Consult a dentist or doctor
Other information Store in a cool, dry place. - Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY WELLNESS SENSITIVE EXTRA WHITENING
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-900 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 5 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM PHOSPHATE (UNII: SE337SVY37) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color white (Sensitive) Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-900-01 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 04/11/2013 Labeler - Family Wellness (024472631)