Label: CREST PRO-HEALTH EXTRA WHITENING POWER- stannous fluoride gel, dentifrice

  • NDC Code(s): 37000-885-03, 37000-885-05, 37000-885-07, 37000-885-35, view more
    37000-885-51
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 31, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Stannous fluoride 0.454%
    (0.16% w/v fluoride ion)

  • Purposes

    Anticavity, antigingivitis, antisensitivity toothpaste

  • Uses

    • aids in the prevention of cavities
    • helps prevent gingivitis
    • helps interfere with the harmful effects of plaque associated with gingivitis
    • helps control plaque bacteria that contribute to the development of gingivitis
    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • Warnings

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

    Stop use and ask a dentist if the sensitivity problem persists or 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.

  • Directions

    • adults and children 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 swallow
    • children under 12 yrs.: ask a dentist
  • Other information

    • products containing stannous fluoride may produce surface staining of the teeth
    • adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
    • this Crest is specially formulated to help prevent staining
    • see your dentist regularly
  • Inactive ingredients

    glycerin, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, trisodium phosphate, flavor, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, xanthan gum, mica, titanium dioxide, blue 1

  • Questions?

    1-800-594-4158

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 144 g Tube Carton

    DEEP CLEANING FORMULA

    Crest® PRO-HEALTH™ ADVANCED


    FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

    WHITENING POWER

    CAVITIES | GINGIVITIS | ACID EROSION | SENSITIVITY | PLAQUE | TARTAR | WHITENING | FRESHENS BREATH

    NET WT 3.5 OZ (99 g)

    Label

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH  EXTRA WHITENING POWER
    stannous fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-885
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    WATER (UNII: 059QF0KO0R)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-885-031 in 1 CARTON01/01/201602/07/2019
    1104 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-885-051 in 1 CARTON01/01/201602/07/2019
    2144 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-885-071 in 1 CARTON01/01/201602/07/2019
    3198 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:37000-885-351 in 1 CARTON01/01/2016
    499 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:37000-885-511 in 1 CARTON01/01/2016
    5144 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2016
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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