Label: CREST 3D WHITE- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-852-01, 37000-852-04, 37000-852-05, 37000-852-07, view more
    37000-852-35, 37000-852-48
  • 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 November 11, 2016

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Sodium fluoride 0.243% (0.16% w/v fluoride ion)

    Close
  • Purpose

    Anticavity toothpaste

    Close
  • Use

    helps protect against cavities

    Close
  • Warning

    Keep out of reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
    • children under 2 yrs.: ask a dentist
    Close
  • Inactive ingredients

    glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, sucralose, xanthan gum, titanium dioxide, mica

    Close
  • Questions?

    1-800-492-7378

    Close
  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

    Close
  • PRINCIPAL DISPLAY PANEL - 99 g Tube Carton

    Crest®
    3D WHITE
    LUXE ®

    FLUORIDE ANTICAVITY
    TOOTHPASTE

    GLAMOROUS
    WHITE ®

    REMOVES UP TO 95% OF SURFACE STAINS
    IN 3 DAYS & PROTECTS AGAINST FUTURE STAINS



    VIBRANT MINT

    NET WT 3.5 OZ (99 g)

    852

    Close
  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-852
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    Color blue Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-852-01 1 in 1 CARTON 02/04/2014
    1 24 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:37000-852-04 1 in 1 CARTON 02/04/2014
    2 116 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:37000-852-05 1 in 1 CARTON 02/04/2014
    3 156 g in 1 TUBE; Type 0: Not a Combination Product
    4 NDC:37000-852-35 1 in 1 CARTON 02/04/2014
    4 99 g in 1 TUBE; Type 0: Not a Combination Product
    5 NDC:37000-852-48 1 in 1 CARTON 02/04/2014
    5 136 g in 1 TUBE; Type 0: Not a Combination Product
    6 NDC:37000-852-07 2 in 1 CELLO PACK 02/04/2014
    6 1 in 1 CARTON
    6 99 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 02/04/2014
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Close