Label: THE NATURAL DENTIST PEPPERMINT TWIST- 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 January 25, 2021

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  • Active ingredient

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

  • Uses

    aids in the prevention of dental cavities

  • WARNINGS

    Stop use and ask a dentist if the sensitivity persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    Do not use if safety seal is broken.

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years and older: Brush teeth thoroughly after meals, at least twice a day or as directed by a dentist. Do not swallow.

    Children under 2 years of age: Consult a dentist or physician.

  • DOSAGE & ADMINISTRATION

    Children 2 to 6 years of age: Use a pea sized amount and supervise until good brushing habits are established. Children under 2 years of age: ask a dentist.

  • Other Information

    Store tube standing up with cap tightly closed.

  • Inactive ingredients

    Hydrated Silica, 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.

  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Tube Label

  • INGREDIENTS AND APPEARANCE
    THE NATURAL DENTIST  PEPPERMINT TWIST
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34362-0270
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    Product Characteristics
    Colorwhite (Off White) Score    
    ShapeSize
    FlavorMINT (Cinnimon Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34362-0270-1142 g in 1 TUBE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/01/2011
    Labeler - Caldwell Consumer Health LLC (828558713)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(34362-0270) , pack(34362-0270)
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