NDC | 10237-668-09, 10237-668-43 |
Set ID | 24d3c1e9-54ce-01d8-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 CLEAN AND FRESH
sodium monofluorophosphate 0.833% paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-668 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.833 mg in 1 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) GLYCERIN (UNII: PDC6A3C0OX) SODIUM BICARBONATE (UNII: 8MDF5V39QO) HYDRATED SILICA (UNII: Y6O7T4G8P9) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) XANTHAN GUM (UNII: TTV12P4NEE) ALUMINUM OXIDE (UNII: LMI26O6933) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor MINT (Clean Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-668-43 1 in 1 CARTON 05/10/2017 1 121 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-668-09 1 in 1 CARTON 05/10/2017 10/10/2019 2 121 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 12/15/2015 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-668)