Label: 28TAK CLAIR TOOTH- silicon dioxide, sodium monofluorophosphate paste, dentifrice
Contains inactivated NDC Code(s)
NDC Code(s): 72440-020-01, 72440-020-02
- Packager: ELMEDITEC CO.,LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated July 17, 2018
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- ACTIVE INGREDIENT
D-Sorbitol Solution, Water, Concentrated Glycerin, Xantangum, Sodium Cocoyl Glutamate, Raspberry Flavor, Black Current Flavor, Xylitol, Chitosan, Rosemary Extract, Matricaria Extract, Eucalyptus Extract, Sage Extract, Aloe Extract, Green Tea Extract, Ascorbic Acid, Tocopherol Acetate
(1) Contains 290ppm of fluoride. (2) Do not swallow and rinse mouth thoroughly after use (3) If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. (4) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. (5) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. (6) Keep out of the reach of children under 6 years of age.
- KEEP OUT OF REACH OF CHILDREN
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 physician
Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
Children under 2 years: Ask a dentist or physician
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
28TAK CLAIR TOOTH
silicon dioxide, sodium monofluorophosphate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72440-020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 4.8 g in 60 g SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.13 g in 60 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Xylitol (UNII: VCQ006KQ1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72440-020-02 1 in 1 CARTON 07/01/2018 1 NDC:72440-020-01 60 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 unapproved drug other 07/01/2018 Labeler - ELMEDITEC CO.,LTD (694771074) Registrant - ELMEDITEC CO.,LTD (694771074) Establishment Name Address ID/FEI Business Operations ELMEDITEC CO.,LTD 694771074 manufacture(72440-020)