Label: CREST COMPLETE MULTI-BENEFIT WHITENING PLUS DEEP CLEAN- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-819-01, 37000-819-04, 37000-819-05, 37000-819-07, view more
    37000-819-11, 37000-819-54, 37000-819-99
  • 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 13, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.243%

  • 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

    sorbitol, water, hydrated silica, PEG-6, sodium lauryl sulfate, flavor, zinc citrate, cellulose gum, carrageenan, sodium saccharin, hydroxyethylcellulose, sodium citrate, stannous chloride, polyethylene, titanium dioxide, blue 1 lake

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by/por Procter & Gamble, Cincinnati, OH 45202
    www.crest.com
    © 2011 P&G

  • PRINCIPAL DISPLAY PANEL - 153 g Tube Carton

    Crest®plus
    complete
    NET WT 5.4 OZ (153 g)

    FLUORIDE TOOTHPASTE

    + WHITENING

    DEEP CLEAN

    UP TO 2X DEEPER CLEAN FEELING*

    effervescent mint

    819

  • INGREDIENTS AND APPEARANCE
    CREST COMPLETE MULTI-BENEFIT  WHITENING PLUS DEEP CLEAN
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-819
    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
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STANNOUS CHLORIDE (UNII: 1BQV3749L5)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    Colorwhite (with Blue stripe and specs) Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-819-051 in 1 CARTON07/01/201106/18/2019
    1164 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:37000-819-011 in 1 CARTON07/01/201107/20/2017
    224 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-819-041 in 1 CARTON07/01/201107/20/2017
    3113 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:37000-819-071 in 1 CARTON07/01/201107/20/2017
    4215 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:37000-819-112 in 1 CARTON07/01/201106/18/2019
    5164 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:37000-819-992 in 1 CARTON01/01/2019
    6153 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:37000-819-541 in 1 CARTON07/01/2011
    7153 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/01/201112/31/2021
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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