DENTI WHOO BLUE TABLETGARGLE- sodium fluoride tablet 
SUN LIFE SCIENCE CO LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Sodium Fluoride

Sodium Bicarbonate
Tartaric Acid
Hydroxypropylcellulose
Hydroxypropyl methylcellulose
Silica
Zea Mays (Corn) Starch
Sodium Cocoyl Glutamate
Maltitol
Mannitol
Erythritol
Potassium Acesulfame
Magnessium Stearate
Brilliant Blue
Menthol
Yucca Vera Leaf/Root Extract

fragrance

Tooth-decay prevention, Odor removal from the mouth and Oral Cleansing

Keep out of reach of children

USAGE : Put 1 tablet in the mouth and use the tongue and lips to rub the gums, teeth, and tongue, gargle it with water, and rinse it several times

1) Observe the specified usage capacity.
2) Store in a cool place with no sunlight and less moisture.
3) Avoid swallowing.
4) This product contains 583 ppm of fluorine.
5) This product contains fluorine, so if you swallow a large amount, consult a doctor or dentist
immediately.
6) When used by children under the age of 6, use under the supervision of their guardians to
avoid swallowing.
7) Keep out of reach of children under the age of 6

For dental use only

label

DENTI WHOO BLUE TABLETGARGLE 
sodium fluoride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86157-0014
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.10037 g
Inactive Ingredients
Ingredient NameStrength
TARTARIC ACID (UNII: W4888I119H)  
MALTITOL (UNII: D65DG142WK)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize15mm
FlavorMENTHOLImprint Code none
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86157-0014-18 in 1 PACKAGE; Type 0: Not a Combination Product04/06/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/06/2022
Labeler - SUN LIFE SCIENCE CO LTD (695149648)
Registrant - SUN LIFE SCIENCE CO LTD (695149648)
Establishment
NameAddressID/FEIBusiness Operations
SUN LIFE SCIENCE CO LTD695149648manufacture(86157-0014)

Revised: 5/2022
Document Id: df330e62-e8ce-7b1f-e053-2a95a90ac0ba
Set id: df330e62-e8cd-7b1f-e053-2a95a90ac0ba
Version: 1
Effective Time: 20220517
 
SUN LIFE SCIENCE CO LTD