Label: HEB HEBUDDY- fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 22, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Sodium Fluoride 0.243%

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    UseHelps protect against cavities

  • WARNINGS

    Warnings

    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.

  • DOSAGE & ADMINISTRATION

    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 doctor.

    • Do not swallow
    • To minimize swallowing use a pea-sized amount in children under 6
    • Supervise childrens brushing until good habits are established

    Children under 2 years of age: consult a dentist or doctor.

  • STORAGE AND HANDLING

    Other information

    Store in a cool dry place. Keep tube capped when not in use.

  • INACTIVE INGREDIENT

    Inactive ingredientssorbitol, water, hydrated silica, glycerin, cellulose gum, PEG-12, flavor, sodium benzoate, sodium saccharin, cocamidopropyl betaine, mica, titanium dioxide, red 40

  • QUESTIONS

    Questions?Call 1-877-777-2743

  • SPL UNCLASSIFIED SECTION

    MADE WITH PRIDE AND CARE FOR H-E-B,

    SAN ANTONIO, TX 78204

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Tube label

  • INGREDIENTS AND APPEARANCE
    HEB  HEBUDDY
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-192
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorWATERMELON (Watermelon mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-192-0012 in 1 CASE12/01/201202/20/2019
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37808-192-02120 g in 1 TUBE; Type 0: Not a Combination Product12/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/01/2012
    Labeler - HEB (007924756)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(37808-192)
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