Label: EVERNAMEL- stannous fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 23, 2023

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  • Active Ingredients

    Stannous Fluoride, 0.454%

  • Purpose

    Anti-cavity & Anti-gingivitis

  • Uses

    • Builds up the enamel of teeth
    • Aids in the prevention of cavities
    • Helps prevent gingivitis
    • Helps sensitive teeth

  • Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 12 years of age.
    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Remove seal
    • Apply a pea-sized amount of paste to the wet toothbrush

    Adults and Children 12 years or older:
    • Brush teeth thoroughly for one minute after ach meal at least twice a day (or as directed by a dentist or physician)
    • Do not swallow

    Children under 12 years of age: ask a dentist

  • Other Information

    • Everest enamel was specially formulated to prevent surface stains on the teeth, which otherwise can occur while using Stannous Fluoride.

    • Adequate tooth brushing may also prevent Stannous Fluoride stains which are not harmful or permanent and can be removed by a Dentist

  • Inactive Ingredients

    Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Sodium Gluconate, Flavor, Zinc Citrate, Quillaja Saponica Bark Extract, Cocamidopropyl Betaine, Titanium Dioxide, Smilax Aristolochiaefolia Root Extract, Sodium Hydroxide, Sodium Hydroxide, Sodium Tripolyphosphate, Tocopheryl Acetate, Xanthan Gum, Natural Menthol, Yucca Schidigera Rooth Extract, Dioscorea Villosa Root Extract

  • Questions or comments?

    Call toll free 1-800-553-3682

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Alpine Dental, Inc.

    Brooklyn, NY 11218

    Made in the USA

    Item Code 1520-10

  • Evernamel

    Brush Your Way To a Brighter Smile

    Fresh Spearmint

    Evernamel

    Toothpaste with Remineralizing Benefits

    Anticavity / Antigingivitis / Sensitivity Relief

    122 g / 4.3 oz.

    20230123_83199_102_43

  • INGREDIENTS AND APPEARANCE
    EVERNAMEL 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83199-102
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.454 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHOL (UNII: L7T10EIP3A)  
    YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)  
    DIOSCOREA VILLOSA WHOLE (UNII: Z95519QROX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83199-102-43122 g in 1 TUBE; Type 0: Not a Combination Product01/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/23/2023
    Labeler - Alpine Dental, Inc. (037301378)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Research, Inc.078444642manufacture(83199-102)
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