TRULY RADIANT WHITENING AND STRENGTHENING RINSE CLEAN AND FRESH- sodium fluoride 0.02% liquid 
Church & Dwight Canada Corp

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.

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DRUG FACTS Truly Radiant Whitening and Strengthening CLEAN AND FRESH Fluoride Rinse

Drug Facts Truly Radiant Fluoride Rinse

Active ingredient

Sodium Fluoride 0.02%

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Warnings

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Directions

Adults and children 6 years of age and older

Children under 6 years of age consult a dentist or doctor

Other Information

Inactive ingredients water, sorbitol, glycerin, propylene glycol, polysorbate 20, poloxamer 407, tetrasodium pyrophosphate, sodium lauryl sulfate, sodium bicarbonate (baking soda), disodium pyrophosphate, flavor, xylitol, sodium saccharin, d&c green 5, d&c red 33

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

Alcohol Free

Truly Radiant

Whitening & Strengthening Fluoride Rinse

CLEAN & FRESH

WHITER SMILE IN JUST 5 DAYS*

Plus Micro-Cleansers & Lasting Freshness

CLEAN MINT

16 FL OZ (473 mL)

Label AHLBFB-00119-01.jpg

Label AHLBFB-00119-01.jpg

TRULY RADIANT  WHITENING AND STRENGTHENING RINSE CLEAN AND FRESH
sodium fluoride 0.02% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62864-665
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorpurpleScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62864-665-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:62864-665-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/02/2015
Labeler - Church & Dwight Canada Corp (253933600)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Canada Corp.253933600manufacture(62864-665)

Revised: 10/2015
Document Id: 21219839-8020-49e5-e054-00144ff88e88
Set id: 21219839-801f-49e5-e054-00144ff88e88
Version: 1
Effective Time: 20151002
 
Church & Dwight Canada Corp