Label: TRULY RADIANT WHITENING AND STRENGTHENING RINSE CLEAN AND FRESH- sodium fluoride 0.02% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 62864-665-08, 62864-665-16 - Packager: Church & Dwight Canada Corp
- 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.
Drug Label Information
Updated October 2, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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
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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)
