Label: ZOHAR TOOTHPASTE REGULAR MINT- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 28, 2011

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  • Active Ingredients

    Sodium monofluorphosphate 1.15% (1500 ppm/ 0.15% w/v fluoride ion)

  • Purpose

    Anticavity

  • Uses

    Aids in the prevention of dental cavities

  • Warnings


    • 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 right away.
  • Directions

    • do not swallow
    • supervise children as necessary until capable of using without supervision.
    adults and children 6 years of age and older
    		 Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
    children 6 to 12 years
    		 instruct in good brushing and rinsing habits(to minimise swallowing)
    children under 6 years
    		 do not use unless directed by dentist or doctor
  • INACTIVE INGREDIENT

    Calcium Carbonate, Water, Glycerine, Hydrated Silica, Sodium Lauryl Sulphate, Silica, Cellulose gum, Flavour, Carvone, Sodium Saccharin, Methylparaben, Limonene

  • Questions?

    call 718 256 9100
    you may also report serious side effects to this phone number

  • Principal Display Panel

    Zohar
    FLUORIDE
    TOOTHPASTE

    REGULAR MINT

    HELPS FIGHT TOOTH DECAY

    Net Wt. 4oz/75mlZohar Fluoride Toothpaste Regular Mint

  • INGREDIENTS AND APPEARANCE
    ZOHAR TOOTHPASTE  REGULAR MINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55754-123
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE11.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CARVONE, (+/-)- (UNII: 75GK9XIA8I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55754-123-011 in 1 CARTON
    1113.4 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/28/2011
    Labeler - Broom Lane Enterprises (211243172)
    Establishment
    NameAddressID/FEIBusiness Operations
    Suzhou City Jinmao Daily Chemicals Co., Ltd547664185manufacture
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