Label: CREST SENSITVITY COMPLETE PROTECTION- stannous fluoride paste, dentifrice

  • NDC Code(s): 37000-899-06, 37000-899-35
  • 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 May 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, water, flavor, trisodium phosphate, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, xanthan gum, blue 1

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - 170g Tube Carton

    Crest®

    PRO-HEALTH
    SENSITIVITY

    FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

    NET WT 6.0 OZ (170 g)

    REPAIRS* PAINFUL SENSITIVITY

    PREVENTS FUTURE SENSITIVITY

    COMPLETE

    PROTECTION
    SMOOTH MINT
    BUILDS A THERAPEUTIC & PROTECTIVE LAYER

    899N

  • INGREDIENTS AND APPEARANCE
    CREST SENSITVITY  COMPLETE PROTECTION
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-899
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    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)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-899-351 in 1 CARTON01/16/201809/02/2020
    199 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-899-061 in 1 CARTON01/16/2018
    2170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/16/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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