DENTI WHOO CTS GERM FREE-F- sodium fluoride liquid 
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 Fluoride
Citric Acid
Sodium Citrate
Stevioside
Xylitol
Chitosan
Citrus paradisi(Grapefruit) Fruit extract
Saponaria Officinalis Extract
hamomilla Recutita (Matricaria) Leaf Extra
Mentol
Fragnance
Glycerin
Water

Tooth-decay prevention, Odor removal from the mouth

Keep out of reach of children

Put about 10 to 15ml in your mouth, gargle for about 30 seconds, and spit it out.

1.General Attention
1) Please observe the prescribed usage and capacity.
2) Do not use it for children under the age of six.
3) Use it under the supervision of guardian when using it for children over the age of seven.
4) This product contains fluorine, so if you drink it incorrectly, consult your doctor or pharmacist.
2. Storage Precautions
1) Keep out of reach of children.
2) Avoid direct sunlight and store in a cool place as much as possible.
3) Do not replace it in other containers to prevent misuse and to preserve quality.

For dental use only

label

DENTI WHOO CTS GERM FREE-F 
sodium fluoride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86157-0003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86157-0003-1250 mL in 1 BOTTLE; 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(86157-0003)

Revised: 5/2022
Document Id: dfe04d1a-2215-2128-e053-2995a90a6ee3
Set id: dbf8efb8-43b0-b15e-e053-2995a90a1379
Version: 2
Effective Time: 20220525
 
SUN LIFE SCIENCE CO LTD