Label: HEB HEBUDDY- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • Active ingredient

    Sodium Fluoride 0.24% ..................................Purpose: Anticavity

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  • Uses

    Helps protect against caviites

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  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children under 6 years of age.

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  • Directions

    Adults and children 2 years of age and older: brush teeth thorughly 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.

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  • Other Information

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

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  • Inactive ingredients

    Water, Sorbitol, Hydrated Silica, Glycerin, Peg-12, Cellulose Gum, Flavor, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Cocamidopropyl Betaine, FD&C Red #40

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  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older: brush teeth throuoghly, preferably after every meal or at least twice a day, or as directed by a dentist or doctor.

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  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Tube label

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  • INGREDIENTS AND APPEARANCE
    HEB  HEBUDDY
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37808-167
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.243 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    WATER  
    SODIUM BENZOATE  
    SORBITOL  
    TITANIUM DIOXIDE  
    SACCHARIN SODIUM  
    COCAMIDOPROPYL BETAINE  
    HYDRATED SILICA  
    TITANIUM DIOXIDE  
    POLYETHYLENE GLYCOL 600  
    CARBOXYMETHYLCELLULOSE SODIUM  
    FD&C RED NO. 40  
    Product Characteristics
    Color pink Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-167-70 12 in 1 CASE
    1 NDC:37808-167-72 119 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 12/01/2012
    Labeler - HEB (007924756)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(37808-167), pack(37808-167)
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