Label: CREST PRO-HEALTH- stannous fluoride paste, dentifrice

  • NDC Code(s): 37000-882-03, 37000-882-04, 37000-882-06, 37000-882-09, view more
    37000-882-30
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2023

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  • Drug Facts

    Active ingredient

    Stannous fluoride 0.454%

    (0.14% 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
  • KEEP OUT OF REACH OF CHILDREN

  • 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

    water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, titanium dioxide, blue 1

  • Questions?

    1-800-594-4158

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • Crest Pro Health Sensitive & Enamel Shield 130 g carton

    Crest®

    FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

    CAVITIES GUM ENAMEL SENSITIVITY PLAQUE TARTAR WITHENING FRESHENS BREATH

    NET WT 4.6 OZ (130 g)

    PRO HEALTH™

    PROTECTS 100% OF THE WHOLE MOUTH*

    SENSITIVE & ENAMEL SHIELD

    *Reaches 100% of mouth surfaces and protects against plaque bacteria that lead to gingivitis

    Crest Pro-Health Sensitive & Enamel Shield

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-882
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-882-041 in 1 CARTON12/19/2016
    1130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-882-061 in 1 CARTON12/19/201606/14/2019
    2178 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-882-031 in 1 CARTON12/19/201606/14/2019
    393 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:37000-882-092 in 1 CELLO PACK12/19/2016
    41 in 1 CARTON
    4130 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:37000-882-303 in 1 CELLO PACK12/19/2016
    51 in 1 CARTON
    5130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/19/2016
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Honeywell Specialty Chemicals Seelze GmbH332940501api manufacture(37000-882)
    Establishment
    NameAddressID/FEIBusiness Operations
    STELLA CHEMIFA CORPORATION695288043api manufacture(37000-882)
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