Label: NATURAL ADULT FLUORIDE- sodium monofluorophosphate paste

  • 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 June 2, 2020

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Sodium monofluorophosphate 0/76% (0.13% w/v fluoride ion) . . . Anticavity

  • PURPOSE

    Uses

    aids in the prevention of dental cavities

  • WARNINGS

    Keep out of reach of children under 6 years of age. If more than is swallowed for brushing si accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice per day, or as directed by a dentist or doctor. * instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) * supervise children as necessary until capable of using without supervision * children under 2 years of age: Consult a dentist or doctor.

  • INACTIVE INGREDIENT

    glycerin, water, calcium carbonate, hydrated silica, xylitol, sodium bicarbonate, carrageenan, sodium lauroyl sarcosinate, flavor, zinc citrate, benzyl alcohol

  • PRINCIPAL DISPLAY PANEL

    Carton Artwork

  • INGREDIENTS AND APPEARANCE
    NATURAL ADULT FLUORIDE 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-223
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    Product Characteristics
    Colorwhite (Off white) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-223-391 in 1 CARTON06/02/2020
    1155.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/02/2020
    Labeler - Kroger (006999528)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(30142-223)