Label: ANTI CAVITY FLUORIDE- sodium monofluorophosphate paste

  • NDC Code(s): 52000-107-01
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 16, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Sodium Monofluorophosphate  0.76%

    (1000 ppm)

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Uses

    • regular brushing with flouride toothpaste helps protect teeth against cavities
    • aids in the prevention of dental cavities.
  • WARNINGS

    Warning

  • WHEN USING

    When using this product

    • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
  • STOP USE

    Stop and ask a dentist

    • if the problem persists or worsens.

    Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age

    • If accidentally swallowed get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children of 2 years and older: brush teeth thoroughly, after meals or at least twice a day, or as directed by a dentist.
    • do not swallow.
    • to minimize swallowing, use a pea-sized amount in children under 6 years old.
    • supervise children's brushing until good habits are established.
    • children under 2 years: ask a dentist before use.

    Children under 12 years of age: Consult a dentist or doctor

  • SPL UNCLASSIFIED SECTION

    Other information

    • store in a cool, dry place.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Calcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose and Flavor

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ANTI-CAVITY FLUORIDE TOOTHPASTE

    label

  • INGREDIENTS AND APPEARANCE
    ANTI CAVITY FLUORIDE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-107
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-107-01181 g in 1 TUBE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/15/2020
    Labeler - Universal Distribution Center LLC (019180459)
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