Label: TRULY RADIANT REJUVENATING WHITENING- sodium fluoride 0.243% paste, dentifrice
- NDC Code(s): 10237-664-09, 10237-664-43
- Packager: Church & Dwight Co., Inc.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 24, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
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 - as a dentist or physician
- INACTIVE INGREDIENT
- QUESTIONS
- Principl Display AHFC-00016-01
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INGREDIENTS AND APPEARANCE
TRULY RADIANT REJUVENATING WHITENING
sodium fluoride 0.243% paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-664 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 SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM BICARBONATE (UNII: 8MDF5V39QO) HYDRATED SILICA (UNII: Y6O7T4G8P9) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) Product Characteristics Color blue (with Blue Twist) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10237-664-43 1 in 1 CARTON 01/05/2015 1 121 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:10237-664-09 1 in 1 CARTON 02/02/2015 10/01/2019 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 01/01/2015 Labeler - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Co., Inc. 043690812 manufacture(10237-664)