Label: THE NATURAL DENTIST WHITENING- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 7, 2018

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  • 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 under 6 years of age. If more than used for brushing is accidentily swallowed, get medical help or contact a Poison Control Center right away. Do not use if the safety seal is missing or broken.

  • 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 child's brushing and rinsing (to minimize swallowing).
    • Children under 2 years: ask a dentist or physician.
  • Inactive Ingredients

    Hydrated silica, vegetable glycerin, sorbitol, water, xylitol, cocamidopropyl betaine, sodium cocoyl glycinate, Aloe barbadensis leaf juice, cellulose gum, Citrus grandis (grapefruit) seed extract, titanium dioxide, xanthan gum, flavor.

  • Other Information

    Store standing up with cap tightly closed.

    QUESTIONS: Call 1-888-317-4402, weekdays 9 to 5 EST.

    TheNaturalDentist.com

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    THE NATURAL DENTIST  WHITENING
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0232
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2430 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    GRAPEFRUIT SEED OIL (UNII: 598D944HOL)  
    Product Characteristics
    Colorwhite (light Off White) Score    
    ShapeSize
    FlavorCINNAMON (Cinnamon Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34362-0232-1142 g in 1 TUBE; Type 0: Not a Combination Product05/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2011
    Labeler - Caldwell Consumer Health, LLC (828558713)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goran Pharma Private Limited828558713manufacture(34362-0232) , pack(34362-0232)
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