Label: CREST PRO-HEALTH COMPLETE PROTECTION BACTERIA SHIELD- stannous fluoride paste, dentifrice

  • NDC Code(s): 69423-916-40, 69423-916-85
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 4, 2021

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

  • 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.
  • Warning

    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 under 12 yrs. of age. 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. of age: 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, carrageenan, sodium gluconate, flavor, xanthan gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • Principal Display Panel - 113 g tube in carton

    Crest®

    PRO-HEALTH™

    FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

    NET WT 4.0 OZ (113 g)

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

    ANTI-BAC 24 HOUR PROTECTION*

    COMPLETE PROTECTION

    BACTERIA SHIELD

    *Protects against plaque bacteria that lead to gingivitis with twice daily brushing

    69423916

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH  COMPLETE PROTECTION BACTERIA SHIELD
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-916
    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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-916-401 in 1 CARTON01/22/2021
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69423-916-851 in 1 CARTON01/22/2021
    224 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/22/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)