ZOHAR TOOTHPASTE COOL MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [BROOM LANE ENTERPRISES]

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  • ZOHAR TOOTHPASTE COOL MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [BROOM LANE ENTERPRISES]

ZOHAR TOOTHPASTE COOL MINT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [BROOM LANE ENTERPRISES]
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NDC 55754-122-01
Set ID 04f24771-fd67-434b-b57b-4324bb5006a0
Category HUMAN OTC DRUG LABEL
Packager Broom Lane Enterprises
Generic Name
Product Class
Product Number
Application Number PART355
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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

    COOL MINT

    HELPS FIGHT TOOTH DECAY

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

  • INGREDIENTS AND APPEARANCE
    ZOHAR TOOTHPASTE  COOL MINT
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55754-122
    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:55754-122-011 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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