NDC | 10237-667-09, 10237-667-43 |
Set ID | 245e99e3-6732-6d2d-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Church & Dwight Co., Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART355 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
Directions
- do not swallow
- supervise children as necessary until capable of using without supervision
- rinse away toothpaste residue thoroughly after brushing
adults and children 2 years and older - brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years - instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years - ask a dentist or physician
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRULY RADIANT BRIGHT AND STRONG
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-667 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 mg in 1 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM LAURYL SULFATE (UNII: 368GB5141J) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BICARBONATE (UNII: 8MDF5V39QO) HYDRATED SILICA (UNII: Y6O7T4G8P9) CALCIUM SULFATE (UNII: WAT0DDB505) SACCHARIN SODIUM (UNII: SB8ZUX40TY) POTASSIUM PHOSPHATE, UNSPECIFIED FORM (UNII: B7862WZ632) PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0) SODIUM CARBONATE (UNII: 45P3261C7T) CALCIUM PEROXIDE (UNII: 7FRO2ENO91) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score Shape Size Flavor MINT (Refreshing Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-667-43 1 in 1 CARTON 05/10/2017 01/31/2023 1 121 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-667-09 1 in 1 CARTON 05/10/2017 01/31/2023 2 25 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/16/2015 01/31/2023 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-667)