Label: DENTI WHOO BLUE TABLETGARGLE- sodium fluoride tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 86157-0006-1 - Packager: SUN LIFE SCIENCE CO LTD
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 6, 2022
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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) 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 - DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTI WHOO BLUE TABLETGARGLE
sodium fluoride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:86157-0006 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.10037 g Inactive Ingredients Ingredient Name Strength TARTARIC ACID (UNII: W4888I119H) MALTITOL (UNII: D65DG142WK) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white Score no score Shape ROUND Size 15mm Flavor MENTHOL Imprint Code none Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86157-0006-1 8 in 1 PACKAGE; 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(86157-0006)