Label: CREST SENSITIVITY WHITENING PLUS SCOPE- sodium fluoride and potassium nitrate paste, dentifrice

  • NDC Code(s): 37000-898-06, 37000-898-12, 37000-898-41
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 March 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Potassium nitrate 5%Toothpaste for sensitive teeth
    Sodium fluoride 0.243% (0.14% w/v fluoride ion)Toothpaste for cavity prevention
  • Uses

    • when used regularly, builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • aids in the prevention of cavities
  • Warnings

    When using this product do not use longer than four weeks unless recommended by a dentist.

    Stop use and ask a dentist if problem lasts or gets worse. 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.

  • Directions

    • do not swallow
    • 12 yrs. & older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 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 use in children under 12 yrs.
  • Inactive ingredients

    water, hydrated silica, glycerin, sorbitol, trisodium phosphate, sodium lauryl sulfate, flavor, cellulose gum, alcohol (1.09%), xanthan gum, sodium saccharin, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

    Crest®

    PRO-HEALTH

    SENSITIVITY

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    NET WT 6.0 OZ (170 g)

    MAXIMUM STRENGTH*
    SENSITIVITY RELIEF

    WHITENING PLUS

    scope ®

    MINTY FRESH

    898

  • INGREDIENTS AND APPEARANCE
    CREST SENSITIVITY  WHITENING PLUS SCOPE
    sodium fluoride and potassium nitrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-898
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ALCOHOL (UNII: 3K9958V90M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-898-411 in 1 CARTON01/01/201806/18/2019
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-898-061 in 1 CARTON01/01/2018
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-898-122 in 1 CARTON01/01/2018
    3170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/01/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jost Chemical Co.147882294api manufacture(37000-898)
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