Label: NEWWORLD- 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 July 8, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

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

  • PURPOSE

    Purpose

    Anticavity toothpaste

  • INDICATIONS & USAGE

    Use

    aids in prevention of dental cavities

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    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 Centre right away.

  • DOSAGE & ADMINISTRATION

    Directions

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

    Inactive ingredients

    calcium carbonate, sorbitol, water, sodium lauryl sulfate, hydrated silica, sodium carboxymethyl cellulose, flavor, sodium silicate, sodium benzoate, sodium saycharin

  • PRINCIPAL DISPLAY PANEL

    PRINCIPALDISPLAY PANELDrug fact panel

  • INGREDIENTS AND APPEARANCE
    NEWWORLD 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72423-0010
    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)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72423-0010-1133 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    2NDC:72423-0010-224 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35507/01/2018
    Labeler - NEW WORLD HEALTHCARE PRIVATE LIMITED (873672074)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEW WORLD HEALTHCARE PRIVATE LIMITED873672074manufacture(72423-0010)
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