Label: DOLLAR GENERAL MAXIMUM STRENGTH- fluoride paste, dentifrice

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

Drug Label Information

Updated January 20, 2025

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Potassium nitrate 5%

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

  • PURPOSE

    Purpose

    Antisensitivity

    Anticavity

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    Wnen using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

    See your dentist if the problem persists or 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.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush.

    • 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.
    • Children under 12 years of age: consult a dentist or a doctor.
  • INACTIVE INGREDIENT

    Inactive ingredients D&C yellow #10, FD& C blue #1, flavor, glycerin, hydrated silica, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, trisodium phosphate, water, xanthan gum

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY DOLGENCORP, LLC

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    MADE IN U.S.A.

  • PRINCIPAL DISPLAY PANEL

    Carton R1

  • INGREDIENTS AND APPEARANCE
    DOLLAR GENERAL  MAXIMUM STRENGTH
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-320
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-320-391 in 1 CARTON01/20/201104/30/2025
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/20/201104/30/2025
    Labeler - Dolgencorp LLC (068331990)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(55910-320)