Label: CREST EXTRA WHITE PLUS SCOPE OUTLAST LONG LASTING MINT- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-693-01, 37000-693-02, 37000-693-04, 37000-693-05, view more
    37000-693-07, 37000-693-10
  • 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 March 4, 2010

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, disodium pyrophosphate, flavor, sodium lauryl sulfate, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, poloxamer 407, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, polyethylene, mica, titanium dioxide, iron oxide, blue 1, yellow 5, blue 1 aluminum lake, yellow 10 aluminum lake

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  • Questions?

    1-800-348-5573

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati, OH 45202
    www.crest.com

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  • PRINCIPAL DISPLAY PANEL - 164 g Carton

    NEW

    Extra Whitening* + Breath Feels Fresh up to 5X Longer+
    +vs. ordinary toothpaste

    Crest

    EXTRA WHITE
    PLUS
    Scope
    Outlast

    FLUORIDE TOOTHPASTE

    NET WT 5.8 OZ (164 g)

    Long Lasting Mint

    Principal Display Panel - 164 g Carton
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  • INGREDIENTS AND APPEARANCE
    CREST EXTRA WHITE PLUS SCOPE OUTLAST   LONG LASTING MINT
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37000-693
    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
    Product Characteristics
    Color GREEN (with white and green specks and sparkles) Score     
    Shape Size
    Flavor PEPPERMINT, WINTERGREEN Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-693-01 2.5 g in 1 POUCH
    2 NDC:37000-693-10 24 g in 1 TUBE
    3 NDC:37000-693-02 1 in 1 CARTON
    3 24 g in 1 TUBE
    4 NDC:37000-693-04 1 in 1 CARTON
    4 113 g in 1 TUBE
    5 NDC:37000-693-05 1 in 1 CARTON
    5 164 g in 1 TUBE
    6 NDC:37000-693-07 1 in 1 CARTON
    6 215 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 09/08/2009
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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