Label: DENTI WHOO CTS GERM FREE-F- sodium fluoride liquid
- NDC Code(s): 86157-0003-1
- Packager: SUN LIFE SCIENCE CO LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated May 25, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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. - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTI WHOO CTS GERM FREE-F
sodium fluoride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:86157-0003 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.05 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86157-0003-1 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/06/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/06/2022 Labeler - SUN LIFE SCIENCE CO LTD (695149648) Registrant - SUN LIFE SCIENCE CO LTD (695149648) Establishment Name Address ID/FEI Business Operations SUN LIFE SCIENCE CO LTD 695149648 manufacture(86157-0003)
