Label: NATURES PROMISE CHILDRENS FLUORIDE STRAWBERRY- sodium monofluorophosphate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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  • ACTIVE INGREDIENT

    Active ingredient

    Sodium Monofluorophosphate 0.76% w/w (0.13% w/v fluoride ion)

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • PURPOSE

    Purpose

    Anticavity

  • INDICATIONS & USAGE

    Use

    helps protect against cavities

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older: brush teeth thorughly preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    Children 2 to 6 years: use a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing).

    ​Children under 2 years of age: consult a dentist or physician.

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauroyl sarcosinate

  • STORAGE AND HANDLING

    Other information

    Store in a cool dry place. Keep tube capped when not in use.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785 • 1-877-846-6649

  • PRINCIPAL DISPLAY PANEL

    Tube R5Nature's Promise

    children's fluoride toothpaste

    strawberry

    • protects against cavities
    • tastes great
    • helps fight tartar

    NET WT 4.2 OZ (119 g)

  • INGREDIENTS AND APPEARANCE
    NATURES PROMISE  CHILDRENS FLUORIDE STRAWBERRY
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-724
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-724-29119 g in 1 TUBE; Type 0: Not a Combination Product02/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/11/2019
    Labeler - Foodhold U.S.A. (809183973)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(41520-724)
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