Label: THE NATURAL DENTIST GROOVY GRAPE- fluoride paste, dentifrice
- NDC Code(s): 34362-0233-1, 34362-0233-2
- Packager: Caldwell Consumer Health LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 16, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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 physician. Children 2 to 6 years Use only a pea sized amount and supervise children's brushing and rinsing (to minimize swallowing.) Children under 2 years Ask a dentist or physician. - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
THE NATURAL DENTIST GROOVY GRAPE
fluoride paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:34362-0233 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.243 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) XYLITOL (UNII: VCQ006KQ1E) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) ALOE VERA LEAF (UNII: ZY81Z83H0X) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) HYDRATED SILICA (UNII: Y6O7T4G8P9) XANTHAN GUM (UNII: TTV12P4NEE) GRAPEFRUIT SEED OIL (UNII: 598D944HOL) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) MICA (UNII: V8A1AW0880) SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM) Product Characteristics Color pink (Faint Pink to clear) Score Shape Size Flavor GRAPE (Grape) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:34362-0233-1 142 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2011 05/23/2013 2 NDC:34362-0233-2 141 g in 1 TUBE; Type 0: Not a Combination Product 05/23/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 05/01/2011 Labeler - Caldwell Consumer Health LLC (828558713) Registrant - GORAN PHARMA PRIVATE LIMITED (862174088) Establishment Name Address ID/FEI Business Operations GORAN PHARMA PRIVATE LIMITED 862174088 manufacture(34362-0233)