DENTI WHOO CTS GUM CARETOOTHPASTE- silicon dioxide, sodium fluoride, tocopherol acetate paste, dentifrice 
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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Silicon Dioxide, Sodium Fluoride, Tocopherol Acetate

Chitosan, Propolis Extract,Xylitol, L-Menthol, Glycyrrhiza Extract, Rosemary Extract, Green Tea Extract, AloeExtract, Sage Extract, Matricaria Extract, Sodium Bicarbonate, Peppermint Oil, SodiumCocoyl Glutamate, D-Sorbitol Solution, Concentrated Glycerin, SodiumCarboxymethylcellulose, Water

(1) Keep your teeth white and strong.(2) Keep your mouth clean.(3) Refresh the inside of the mouth.(4) Prevent tooth decay and remove bad breath due to fluorine.(5) Increase the esthetic effect.(6) Prevention of gingivitis and periodontitis(alveolar fistula)(7) Prevention of periodontal disease and gum disease(8) Plaque removal(anti-plaque)

Keep out of reach of children

Brushing the teeth with a suitable amount

(1) The fluoride content of this toothpaste is 1,000 ppm.(2) Do not swallow and rinse mouth thoroughly after use(3) If you experience any problems with your gums or mouth during use,discontinue use and consult your doctor(4) For children under 6 years of age, use small amounts of toothpaste. And use itunder the supervision of a guardian to avoid sucking or swallowing(5) Consult a physician or dentist immediately if a child under 6 years old hasswallowed large quantities(6) Keep out of the reach of children under 6 years of age

For dental use only

label

DENTI WHOO CTS GUM CARETOOTHPASTE 
silicon dioxide, sodium fluoride, tocopherol acetate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86157-0013
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86157-0013-150 g in 1 TUBE; 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(86157-0013)

Revised: 5/2022
Document Id: df32f965-2b0c-64f2-e053-2a95a90a654c
Set id: df32e6c1-7bb1-d058-e053-2995a90abf7b
Version: 1
Effective Time: 20220517
 
SUN LIFE SCIENCE CO LTD