BURTS BEES ENAMEL CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]

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BURTS BEES ENAMEL CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 37000-922-47, 37000-922-85
Set ID 7a90471c-72b5-6560-e053-2a91aa0a6e43
Category HUMAN OTC DRUG LABEL
Packager Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number PART355
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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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