Label: CREST CAVITY PROTECTION REGULAR- sodium fluoride paste, dentifrice

  • NDC Code(s): 37000-005-01, 37000-005-02, 37000-005-03, 37000-005-04, view more
    37000-005-05, 37000-005-08, 37000-005-09, 37000-005-10, 37000-005-11, 37000-005-13, 37000-005-20, 37000-005-24, 37000-005-29, 37000-005-42, 37000-005-57, 37000-005-90, 37000-005-99
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

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

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect teeth and roots 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, sodium lauryl sulfate, trisodium phosphate, flavor, cellulose gum, sodium phosphate, carbomer, sodium saccharin, titanium dioxide, blue 1

  • Questions?

    1-800-492-7378

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble, Cincinnati OH 45202

    www.crest.com

  • PRINCIPAL DISPLAY PANEL - 161 g Carton

    HELPS STOP CAVITIES BFORE THEY START

    Crest®

    ADA
    ACCEPTED
    American
    Dental
    Association®

    FLUORIDE ANTICAVITY TOOTHPASTE

    NET WT 5.7 OZ (161 g)

    CAVITY
    PROTECTION

    Regular Paste

    005

  • INGREDIENTS AND APPEARANCE
    CREST CAVITY PROTECTION REGULAR 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-005
    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
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-005-012.5 g in 1 POUCH; Type 0: Not a Combination Product08/02/1984
    2NDC:37000-005-031 in 1 CARTON08/02/198412/01/2021
    2130 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:37000-005-041 in 1 CARTON08/02/198412/01/2021
    3181 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:37000-005-051 in 1 CARTON08/02/1984
    4232 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:37000-005-101 in 1 CARTON08/02/1984
    5NDC:37000-005-0824 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:37000-005-09170 g in 1 TUBE; Type 0: Not a Combination Product08/02/198406/08/2018
    7NDC:37000-005-132 in 1 CARTON08/02/198412/01/2021
    7181 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:37000-005-203 in 1 CELLO PACK08/02/198412/01/2021
    81 in 1 CARTON
    8181 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:37000-005-021 in 1 CARTON01/01/201512/01/2021
    983 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:37000-005-291 in 1 CARTON08/02/198412/01/2021
    1082 g in 1 TUBE; Type 0: Not a Combination Product
    11NDC:37000-005-241 in 1 CARTON09/10/2019
    1168 g in 1 TUBE; Type 0: Not a Combination Product
    12NDC:37000-005-421 in 1 CARTON09/10/2019
    12119 g in 1 TUBE; Type 0: Not a Combination Product
    13NDC:37000-005-571 in 1 CARTON09/10/2019
    13161 g in 1 TUBE; Type 0: Not a Combination Product
    14NDC:37000-005-112 in 1 CARTON09/10/2019
    14161 g in 1 TUBE; Type 0: Not a Combination Product
    15NDC:37000-005-903 in 1 CELLO PACK09/10/2019
    151 in 1 CARTON
    15161 g in 1 TUBE; Type 0: Not a Combination Product
    16NDC:37000-005-994 in 1 CELLO PACK09/10/201907/25/2023
    161 in 1 CARTON
    16161 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02108/02/1984
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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