Label: CREST PRO-HEALTH STAGES- sodium fluoride paste, dentifrice 

  • NDC Code(s): 37000-673-04
  • Packager: Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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% (0.15% w/v fluoride ion)

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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

    • twist off cap to remove foil seal
    • 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, sodium lauryl sulfate, trisodium phosphate, cellulose gum, flavor, sodium phosphate, sodium saccharin, carbomer, red 28

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  • Questions?

    1-800-285-9139

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  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati, OH 45202

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  • PRINCIPAL DISPLAY PANEL - 120 g Tube Label

    2+
    years

    Bubble
    Gum

    Disney
    PRINCESS

    ANTICAVITY FLUORIDE TOOTHPASTE

    Crest®

    PRO-HEALTH®
    Stages®

    NET WT 4.2 OZ (120 g)

    PRINCIPAL DISPLAY PANEL - 120 g Tube Label
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  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH STAGES 
    sodium fluoride paste, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37000-673
    Route of Administration DENTAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sodium Fluoride (Fluoride Ion) Fluoride Ion 2.43 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    sorbitol  
    water  
    hydrated silica  
    sodium lauryl sulfate  
    carboxymethylcellulose sodium  
    sodium phosphate  
    saccharin sodium  
    D&C red no. 28  
    Product Characteristics
    Color PINK Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37000-673-04 120 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 08/01/2008
    Labeler - Procter & Gamble Manufacturing Company (004238200)
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