Label: PRIYAL- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 9, 2020

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  • Active Ingredient

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

  • Purpose

    Anticavity toothpaste

  • Uses

    aids in the prevention of dental cavities

  • Warning

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

  • WARNINGS

    If more than used for brushing is accidently 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 ■ instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing) ■ 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 doctor ■ children under 6 years of age: do not use unless directed by a doctor or dentist

  • Inactive ingredients

    calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose,Flavor, sodium saccharin, sodium methylparaben, sodium propylparaben

  • Package Label

    Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    PRIYAL 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72822-900
    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)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72822-900-5343 g in 1 TUBE; Type 0: Not a Combination Product05/27/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/27/2013
    Labeler - Priyal Cosmetics (675482356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Priyal Cosmetics675482356manufacture(72822-900)
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