Label: GO SMILE LUXURY AM- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 44873-106-11, 44873-106-13
- Packager: Go Smile, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
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DIRECTIONS
- ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: BRUSH TEETH THOROUGHLY FOR TWO MINUTES AT LEAST TWICE A DAY PREFERABLY AFTER EACH MEAL OR AS DIRECTED BY A DOCTOR OR DENTIST. THIS PRODUCT SHOULD BE USED AS PART OF AN ORAL HEALTH PROGRAM THAT INCLUDES REGULAR FLOSSING AND DENTAL CHECK-UPS.
- INSTRUCT CHILDREN UNDER 6 YEARS OF AGE IN GOOD BRUSHING AND RINSING HABITS (TO MINIMIZE SWALLOWING). SUPERVISE CHILDREN AS NECESSARY UNTIL CAPABLE OF USING WITHOUT SUPERVISION.
- CHILDREN UNDER TWO YEARS OF AGE: CONSULT A DENTIST OR A DOCTOR.
- INACTIVE INGREDIENTS
- OTHER INFORMATION
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GO SMILE LUXURY AM
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44873-106 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.13 g in 100 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LAURYL SULFATE (UNII: 368GB5141J) CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44873-106-13 100 g in 1 TUBE; Type 0: Not a Combination Product 10/27/2015 2 NDC:44873-106-11 28 g in 1 TUBE; Type 0: Not a Combination Product 10/27/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M021 10/27/2015 Labeler - Go Smile, Inc. (139729631)