Label: CREST PRO-HEALTH HD- stannous fluoride kit

  • NDC Code(s): 37000-856-04
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 5, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Stannous fluoride 0.454% (0.15% w/v fluoride ion)

  • Purposes

    Anticavity, antigingivitis 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
  • Warning

    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. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
      • do not swallow
    • children under 12 yrs. of age: 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
    • see your dentist regularly

    Inactive ingredients

    glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, polyethylene, mica, titanium dioxide, blue 1 lake

  • Questions?

    (800) 492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NEW! DAILY 2-STEP SYSTEM

    Crest®
    PRO-HEALTH®
    [HD]™

    FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS | WHITENING GEL

    — FEEL A DIFFERENCE FROM FIRST USE —

    Upgrade to a healthier & more luminescent smile*

    1 TUBE NET WT 4.0 OZ (113 g) & 1 TUBE NET WT 2.3 OZ (65 g)

    96313003

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH HD 
    stannous fluoride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-856
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-856-041 in 1 CARTON; Type 1: Convenience Kit of Co-Package03/15/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 113 g
    Part 21 TUBE 65 g
    Part 1 of 2
    CREST PRO-HEALTH HD STEP 1  PURIFYING CLEANSER
    stannous fluoride paste, dentifrice
    Product Information
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/15/2014
    Part 2 of 2
    CREST PRO-HEALTH HD STEP 2  WHITENING GEL
    other oral hygiene products gel, dentifrice
    Product Information
    Route of AdministrationDENTAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRHYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    INGRSODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    INGRSUCRALOSE (UNII: 96K6UQ3ZD4)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    165 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/15/2014
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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