Label: DENTI WHOO CTS GUM CARETOOTHPASTE- silicon dioxide, sodium fluoride, tocopherol acetate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 86157-0013-1 - 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 17, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
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PURPOSE
(1) Keep your teeth white and strong.(2) Keep your mouth clean.(3) Refresh the inside of the mouth.(4) Prevent tooth decay and remove bad breath due to fluorine.(5) Increase the esthetic effect.(6) Prevention of gingivitis and periodontitis(alveolar fistula)(7) Prevention of periodontal disease and gum disease(8) Plaque removal(anti-plaque)
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
(1) The fluoride content of this toothpaste is 1,000 ppm.(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 itunder the supervision of a guardian to avoid sucking or swallowing(5) Consult a physician or dentist immediately if a child under 6 years old hasswallowed large quantities(6) Keep out of the reach of children under 6 years of age
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DENTI WHOO CTS GUM CARETOOTHPASTE
silicon dioxide, sodium fluoride, tocopherol acetate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:86157-0013 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 SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 15 g in 100 g .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 0.2 g in 100 g Inactive Ingredients Ingredient Name Strength XYLITOL (UNII: VCQ006KQ1E) WATER (UNII: 059QF0KO0R) LEVOMENTHOL (UNII: BZ1R15MTK7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86157-0013-1 50 g in 1 TUBE; 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(86157-0013)
