Label: HEB EXTRA WHITENING- sodium fluoride and potassium nitrate paste, dentifrice 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/12

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

  • Active ingredients / Purpose

    Potassium nitrate 5%....................................................Antihypersensitivity

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

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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. See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    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, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

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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: consult a dentist or a 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

    cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

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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:37808-961
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.24 g  in 100 g
    POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE 5.0 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SACCHARIN SODIUM  
    SODIUM TRIPOLYPHOSPHATE  
    POLYETHYLENE GLYCOL 400  
    SORBITOL  
    TITANIUM DIOXIDE  
    SODIUM HYDROXIDE  
    GLYCERIN  
    XANTHAN GUM  
    HYDRATED SILICA  
    COCAMIDOPROPYL BETAINE  
    SODIUM METHYL COCOYL TAURATE  
    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:37808-961-19 1 in 1 CARTON
    1 NDC:37808-961-12 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 01/20/2011
    Labeler - HEB (007924756)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(37808-961), pack(37808-961)
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