Label: TOPCARE SENSITIVE EXTRA WHITENING- potassium nitrate, sodium fluoride paste, dentifrice

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

Drug Label Information

Updated February 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Potassium nitrate 5%

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

  • PURPOSE

    Purpose

    Antihypersensitivity

    Anticavity

  • INDICATIONS & USAGE

    Uses

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

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and older: Apply at least 1-inch strip of the 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 physician.
  • STORAGE AND HANDLING

    Other information

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

  • INACTIVE INGREDIENT

    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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    QUESTIONS? 1-888-423-0139 topcare@topco.com

    www.topcarebrand.com

  • PRINCIPAL DISPLAY PANEL

    Carton Artwork

  • INGREDIENTS AND APPEARANCE
    TOPCARE SENSITIVE  EXTRA WHITENING
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-451
    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
    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 TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-451-591 in 1 CARTON01/20/2011
    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 DrugM02201/20/2011
    Labeler - TOPCO Assoc. LLC (006935977)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(36800-451)
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