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
  • Packager: 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 December 5, 2011

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sodium fluoride 0.243%

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  • Purpose

    Anticavity toothpaste

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  • Use

    helps protect against cavities

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  • 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.

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  • 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
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  • 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

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  • Questions?

    1-800-492-7378

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  • SPL UNCLASSIFIED SECTION

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

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  • PRINCIPAL DISPLAY PANEL - 164 g Tube Carton

    NEW

    Fights Cavities, Whitens + Lasting Clean Feeling

    Crest®
    complete
    MULTI-BENEFIT

    FLUORIDE TOOTHPASTE

    NET WT 5.8 OZ (164 g)

    WHITENING +

    DEEP CLEAN

    effervescent mint

    Principal Display Panel - 164 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CREST COMPLETE MULTI-BENEFIT   WHITENING PLUS DEEP CLEAN
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-819
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE (with Blue stripe and specs) Score     
    Shape Size
    Flavor PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-819-05 1 in 1 CARTON
    1 164 g in 1 TUBE
    2 NDC:37000-819-01 1 in 1 CARTON
    2 24 g in 1 TUBE
    3 NDC:37000-819-04 1 in 1 CARTON
    3 113 g in 1 TUBE
    4 NDC:37000-819-07 1 in 1 CARTON
    4 215 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 07/01/2011
    Labeler - Procter & Gamble Manufacturing Company (004238200)
    Establishment
    Name Address ID/FEI Business Operations
    The Procter & Gamble Manufacturing Company 017745779 MANUFACTURE(37000-819)
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