Label: HEB EXTRA WHITENING- stannous 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

    Stannous fluoride 0.454% (0.16% w/v fluoride ion)............Anticavity, Antisensitivity

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  • Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities
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  • WARNINGS

    When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. Stop use and ask a dentist if the sensitivity problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care.

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

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  • Directions

    Brush teeth thoroughly for at least one minute, twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.

    Do not swallow

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  • DOSAGE & ADMINISTRATION

    Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: ask a dentist.

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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, hydrated silica, glycerin, propylene glycol, PEG-6, sodium tripolyphosphate, zinc lactate, trisodium phosphate, monosodium phosphate, flavor, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, polyethylene, xanthan

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  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

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  • INGREDIENTS AND APPEARANCE
    HEB  EXTRA WHITENING
    fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37808-171
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    STANNOUS FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.4540 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    ZINC LACTATE  
    SACCHARIN SODIUM  
    POLYETHYLENE GLYCOL 600  
    SODIUM PHOSPHATE, TRIBASIC  
    SODIUM TRIPOLYPHOSPHATE  
    SODIUM GLUCONATE  
    PROPYLENE GLYCOL  
    XANTHAN GUM  
    HYDRATED SILICA  
    GLYCERIN  
    SODIUM PHOSPHATE  
    CHONDRUS CRISPUS  
    TITANIUM DIOXIDE  
    SODIUM LAURYL SULFATE  
    HIGH DENSITY POLYETHYLENE  
    FD&C BLUE NO. 1  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor MINT (mint) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-171-19 1 in 1 CARTON
    1 NDC:37808-171-12 170 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(37808-171), pack(37808-171)
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