Label: ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR- sodium monofluorophosphate paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 27, 2024

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  • Drug Facts

  • Active ingredients

    Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)

    Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warnings

    Do not use if

    irritation occurs and persists.

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

     • Do not swallow • Supervise children as necessary until capable of using without supervision.

     Adults and children 2 years of age 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 Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
     Children under 2 years Ask a dentist or physician

  • Inactive ingredients

    Calcium Carbonate, Glycerin, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Benzoate, Spearmint Oil, Laevo Carvone, Flavor, Sodium Saccharin.

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    ZOHAR FLUORIDE ANTI-CAVITY REGULAR MINT FLAVOUR 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84045-005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84045-005-001 in 1 CARTON03/15/2024
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/15/2024
    Labeler - ZOHAR KOSHER LIMITED (221033261)
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