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

  • NDC Code(s): 37000-851-01, 37000-851-02, 37000-851-04, 37000-851-05, view more
    37000-851-07
  • 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 April 1, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Sodium fluoride 0.243% (0.14% 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

    water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, sodium saccharin, carbomer, xanthan gum, polyethylene, mica, titanium dioxide, blue 1 lake

    Close
  • Questions?

    1-800-492-7378

    Close
  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202

    Close
  • PRINCIPAL DISPLAY PANEL - 198 g Tube Carton

    3D
    Crest®
    WHITE

    REMOVES UP TO 80%
    OF SURFACE STAINS.

    WHITER TEETH. 100% GUARANTEED.*

    RADIANT MINT

    NET WT 7.0 OZ (198 g)
    FLUORIDE ANTICAVITY TOOTHPASTE
    ENAMEL SAFE WHITENING

    Principal Display Panel - 198 g Tube Carton
    Close
  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-851
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    sorbitol (UNII: 506T60A25R)  
    hydrated silica (UNII: Y6O7T4G8P9)  
    sodium acid pyrophosphate (UNII: H5WVD9LZUD)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    carboxymethylcellulose sodium (UNII: K679OBS311)  
    sodium hydroxide (UNII: 55X04QC32I)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    xanthan gum (UNII: TTV12P4NEE)  
    mica (UNII: V8A1AW0880)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    fd&c blue no. 1 (UNII: H3R47K3TBD)  
    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:37000-851-01 1 in 1 CARTON
    1 24 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:37000-851-02 1 in 1 CARTON
    2 70 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:37000-851-04 1 in 1 CARTON
    3 113 g in 1 TUBE; Type 0: Not a Combination Product
    4 NDC:37000-851-05 1 in 1 CARTON
    4 156 g in 1 TUBE; Type 0: Not a Combination Product
    5 NDC:37000-851-07 1 in 1 CARTON
    5 198 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