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

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium fluoride (0.24%)(0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use

    Aids in the prevention of dental cavities.

  • WARNINGS

    Warnings

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and olderBrush teeth thoroughly preferably after each meal or at least twice a day, or as directed by a dentist or physician.
    Children 2 to 6 yearsUse only a pea sized amount and supervise children's brushing and rinsing (to minimize swallowing.)
    Children under 2 yearsAsk a dentist or physician.
  • STORAGE AND HANDLING

    Other information

    Store tube standing up with cap tightly closed.

  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, water, sorbitol, hydrated silica, xylitol, Aloe barbadensis leaf juice, cocamidopropyl betaine, sodium cocoyl glycinate, cellulose gum, flavor, xanthan gum, Citrus grandis (grapefruit) seed extract, mica, Stevia rebaudiana extract, titanium dioxide,

  • QUESTIONS

    Questions?

    Call 1-888-317-4402, weekdays 9 to 5 ET.

  • SPL UNCLASSIFIED SECTION

    Manufactured for Revive Personal Care Products Company Allendale, NJ 07401

    ©2018 Revive Personal Products Company. Made in the USA. Vegan. Not tested on animals.

  • PRINCIPAL DISPLAY PANEL

    THE NATURAL DENTIST®

    CAVITY ZAPPER®

    ANTICAVITY GEL TOOTHPASTE FOR KIDS

    • Helps Prevent Cavities
    • Strengthens Tooth Enamel
    • Cleans Away Plaque & Stains

    NOT YUCKY GRAPE

    No Sodium Lauryl Sulfate

    No artificial flavors or colors.

    NET WT 5.0 OZ (141 g)

    image description

  • INGREDIENTS AND APPEARANCE
    THE NATURAL DENTIST  GROOVY GRAPE
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0233
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.243 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    Colorpink (Faint Pink to clear) Score    
    ShapeSize
    FlavorGRAPE (Grape) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34362-0233-1142 g in 1 TUBE; Type 0: Not a Combination Product05/01/201105/23/2013
    2NDC:34362-0233-2141 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/01/2011
    Labeler - Caldwell Consumer Health LLC (828558713)
    Registrant - GORAN PHARMA PRIVATE LIMITED (862174088)
    Establishment
    NameAddressID/FEIBusiness Operations
    GORAN PHARMA PRIVATE LIMITED862174088manufacture(34362-0233)
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