Label: DOCTRUST DOUBLEX TOOTH- sodium fluoride paste, dentifrice
- NDC Code(s): 76670-0010-1, 76670-0010-2
- Packager: DOCSMEDI OralBiome Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 5, 2023
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENTS
Sodium Tocopheryl Acetate, Silicon Dioxide, Chitosan, Propolis Extract, D-sorbitol Solution, Sodium Carboxymethyl Cellulose, Licorice Extract, Ascorbic Acid, Camellia Sinensis Extract, Curcumin Extract, Xylitol, Enzymatically Modified Stevia, Sodium Cocoylglutamate, Sodium Bicarbonate, L-menthol, Peppermint Oil, Purified Water
- PURPOSE
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WARNINGS
■ Do not swallow and rinse mouth thoroughly after use
■ For children under 6 years of age, use small amounts of toothpaste.
under the supervision of a guardian to avoid sucking or swallowing.
■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.
■ Keep out of the reach of children under 6 years of age. - KEEP OUT OF REACH OF CHILDREN
- Uses
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Directions
■ Adults and children 2 years of age and older: Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or doctor.
■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
■ Children under 2 years: Consult a dentist or doctor. - Other Information
- Questions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DOCTRUST DOUBLEX TOOTH
sodium fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76670-0010 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength Silicon Dioxide (UNII: ETJ7Z6XBU4) PROPOLIS WAX (UNII: 6Y8XYV2NOF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76670-0010-2 1 in 1 CARTON 10/01/2021 1 NDC:76670-0010-1 100 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 10/01/2021 Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169) Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(76670-0010)