Label: CREST 3D WHITE WHITENING THERAPY CHARCOAL WITH GINGER OIL- sodium fluoride gel, dentifrice

  • NDC Code(s): 37000-967-41
  • Packager: Procter & Gamble Manfuacturing 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 15, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243% (0.15% w/v fluoride ion)

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warnings

    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.

  • 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
  • Inactive ingredients

    water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, sodium hydroxide, flavor, cellulose gum, sodium saccharin, zingiber officinale (ginger) root oil,, carbomer, charcoal powder, sucralose, polysorbate 80, mica, titanium dioxide

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 116 g Carton

    Crest®

    3D WHITE™

    FLUORIDE ANTICAVITY TOOTHPASTE

    WHITENING

    THERAPY

    ENERGIZING CLEAN

    charcoal

    with

    GINGER OIL

    Our Toothpaste

    Actively Refreshes

    & Removes Stains

    ZESTY MINT

    NET WT 4.1 OZ (116 g)

    967

  • INGREDIENTS AND APPEARANCE
    CREST 3D WHITE WHITENING THERAPY  CHARCOAL WITH GINGER OIL
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-967
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MICA (UNII: V8A1AW0880)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Product Characteristics
    ColorblackScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-967-411 in 1 CARTON01/02/2020
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/02/2020
    Labeler - Procter & Gamble Manfuacturing Company (004238200)