DRUG FACTS Truly Radiant Whitening & Strengthening Fluoride Rinse Clean and Fresh

Drug Labeling and Warnings

Drug Details [pdf]

TRULY RADIANT CLEAN AND FRESH FLUORIDE RINSE- sodium fluoride 0.02% liquid 
Church & Dwight Co., Inc.

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 & Strengthening Fluoride Rinse Clean and Fresh

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

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10mL (2 teaspoons) of rinse between your teeth for a least one 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 Information

  • do not use if safety seal is broken or missing

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 CLEAN & FRESH

Alcohol FREE

Truly Radiant

Whitening & Strengthening Fluoride Rinse

CLEAN & FRESH

WHITER SMILE IN JUST 5 DAYS*

Plus Micro-Cleansers & Lasting Freshness

  • PEROXIDE-FREE Whitening
  • Fights Cavities & Strengthens Enamel
  • Cleans Where Brushing May Miss

CLEAN MINT

16 FL OZ (473 mL)

Label AHLBFB-00119-01.jpg

Label AHLBFB-00119-01.jpg

TRULY RADIANT  CLEAN AND FRESH FLUORIDE RINSE
sodium fluoride 0.02% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10237-665
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
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
XYLITOL (UNII: VCQ006KQ1E)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10237-665-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product10/02/201510/10/2019
2NDC: 10237-665-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product10/02/201510/10/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35510/02/201510/10/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Canada Corp.253933600manufacture(10237-665)

Revised: 10/2019
Document Id: 94917541-7049-9f90-e053-2a95a90af929
Set id: 21210b24-e5e0-20fb-e054-00144ff8d46c
Version: 3
Effective Time: 20191010