Label: TRULY RADIANT CLEAN AND FRESH- sodium monofluorophosphate 0.833% paste, dentifrice
- NDC Code(s): 10237-668-09, 10237-668-43
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 24, 2023
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- 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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
TRULY RADIANT CLEAN AND FRESH
sodium monofluorophosphate 0.833% paste, dentifrice
Product 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 (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)