![TRULY RADIANT WHITENING AND STRENGTHENING RINSE CLEAN AND FRESH (SODIUM FLUORIDE 0.02%) LIQUID [CHURCH & DWIGHT CANADA CORP]](https://medic.hrt.org//dailymed/images/21219839-801f-49e5-e054-00144ff88e88/AHLBFB-00119-01.jpg)
| NDC | 62864-665-08, 62864-665-16 |
| Set ID | 21219839-801f-49e5-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Church & Dwight Canada Corp |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART355 |
- Drug Facts Truly Radiant Fluoride Rinse
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Adults and children 6 years of age and older
- use twice a day after brushing your teeth with a toothpaste
- vigorously swish 10mL (2 teaspoons) of rinse between your teeth for a least 1 minue then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
Children under 6 years of age consult a dentist or doctor
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
-
QUESTIONS
Questions or commentscall us at 1–800–786-5135 M–F 9am–5pm ET or visit our website atwww.TrulyRadiant.com
- Truly Radiant Whitening & Strengthening Fluoride Rinse
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INGREDIENTS AND APPEARANCE
TRULY RADIANT WHITENING AND STRENGTHENING RINSE CLEAN AND FRESH
sodium fluoride 0.02% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62864-665 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM PYROPHOSPHATE (UNII: O352864B8Z) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD) SODIUM BICARBONATE (UNII: 8MDF5V39QO) XYLITOL (UNII: VCQ006KQ1E) SACCHARIN SODIUM (UNII: SB8ZUX40TY) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) POLYSORBATE 20 (UNII: 7T1F30V5YH) Product Characteristics Color purple Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62864-665-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62864-665-08 237 mL in 1 BOTTLE; 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 10/02/2015 Labeler - Church & Dwight Canada Corp (253933600) Registrant - Church & Dwight Co., Inc. (001211952) Establishment Name Address ID/FEI Business Operations Church & Dwight Canada Corp. 253933600 manufacture(62864-665)
