Label: BURTS BEES ENAMEL CARE- sodium 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 12, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.13% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warnings

    Keep out of reach of children under 6 yrs 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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children’s brushing until good habits are established
    • children under 2 yrs.: ask a dentist
  • Inactive ingredients

    glycerin, water, hydrated silica, sodium cocoyl glutamate*, cocamidopropyl betaine*, flavor**, xanthan gum, carrageenan, stevia rebaudiana extract, titanium dioxide

  • Questions?

    1-855-248-5352

  • SPL UNCLASSIFIED SECTION

    *contains one of these ingredients
    **Peppermint Oil and other Natural Flavor

  • SPL UNCLASSIFIED SECTION

    DISTR. BY SUNFLOWER DISTRIBUTING
    LLC, CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 133 g tube in carton

    BURT'S

    BEES®

    ENAMEL

    CARE

    FLUORIDE

    Toothpaste

    Mountain

    Mint

    NET WT 4.7 OZ (133 g)

    922

  • INGREDIENTS AND APPEARANCE
    BURTS BEES  ENAMEL CARE
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-922
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-922-471 in 1 CARTON10/24/2018
    1133 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-922-851 in 1 CARTON01/08/2019
    224 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/24/2018
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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