Label: DENTREE- sodium fluoride gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 76170-103-01, 76170-103-02, 76170-103-03 - Packager: E-SOUP Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated April 20, 2020
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- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
Adults and children 6 years of age and older
Brushless: shake the container before pumping 2-3 times on a toothbrush to brush the teeth or into mouth for close-mouthed; gurgle the foam inside the mouth for about 30 seconds. Rinse off the residue with clean water several times to achieve the intended cleanliness.
With Brush: after gurgle the foam inside the mouth for about 30 seconds, you may use toothbrush to clean before rinse.
Children under 6 years old
ask a dentist or physician - Other Information
- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTREE
sodium fluoride gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76170-103 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.22 g in 100 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) GINGER (UNII: C5529G5JPQ) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) LIGUSTICUM WALLICHII WHOLE (UNII: 8Y1N3NX2DW) ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G) WATER (UNII: 059QF0KO0R) Product Characteristics Color green Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76170-103-01 1 in 1 CARTON 12/01/2012 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:76170-103-02 1 in 1 CARTON 12/01/2012 2 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 3 NDC:76170-103-03 1 in 1 CARTON 12/01/2012 3 100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 12/01/2012 Labeler - E-SOUP Co., Ltd. (557805059) Establishment Name Address ID/FEI Business Operations E-SOUP Co., Ltd 557805059 manufacture(76170-103)