Label: SODIUM MONOFLUOROPHOSPHATE- white toothpaste paste

  • NDC Code(s): 67777-181-01, 67777-181-02, 67777-181-03, 67777-181-04, view more
    67777-181-05, 67777-181-06, 67777-181-07, 67777-181-08, 67777-181-09, 67777-181-10, 67777-181-11, 67777-181-12, 67777-181-13
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 3, 2024

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  • Active Ingredient

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity

  • Use(s)

    Helps protect against cavities

  • Warnings

    If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center (1-800-222-1222) immediatley.

    Keep out of reach of children

    Keep out of reach of childen under 6 years of age

  • Directions

    • Adults and children 2 years and older: Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician.

    • Children under 6 years: To minimize swallowing, use a pea sized amount and supervise child's brushing and rinsing until good habits are established.

    • Children under 2 years: Ask a dentist or physician.

  • Inactive Ingredients

    Calcium Carbonate, Carboxymethylcellulose Sodium, Hydrated Silica, Peppermint Oil, Purified Water, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, Sodium Silicate, Sorbitol, Titanium Dioxide

  • Other Information

    Store between 15°-35ºC (59º-95ºF)

  • Questions?

    1-888-396-2739 Monday - Friday 9AM - 5PM EST

  • Label

    5910_IN_MASTER5910 White Toothpaste

  • Label

    5911_IN_MASTER5911 White Toothpaste

  • Label

    5912_BX_MASTER5912 White Toothpaste

  • Label

    5913_BX_MASTER5913 White Toothpaste

  • Label

    4914_BX_MASTER5914 White Toothpaste

  • INGREDIENTS AND APPEARANCE
    SODIUM MONOFLUOROPHOSPHATE 
    white toothpaste paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-181
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION760 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-181-02144 in 1 CASE07/16/2024
    1NDC:67777-181-0142.5 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67777-181-04144 in 1 CASE07/16/2024
    2NDC:67777-181-0378 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:67777-181-0760 in 1 CASE07/16/2024
    3NDC:67777-181-061 in 1 BOX
    3NDC:67777-181-05130 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:67777-181-10720 in 1 CASE07/16/2024
    4NDC:67777-181-09144 in 1 BOX
    4NDC:67777-181-0824 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:67777-181-13720 in 1 CASE07/16/2024
    5NDC:67777-181-12144 in 1 BOX
    5NDC:67777-181-1117 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/16/2024
    Labeler - Dynarex Corporation (008124539)
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