LUCKY SUPER SOFT ANTI CAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DELTA BRANDS INC]

LUCKY SUPER SOFT ANTI CAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [DELTA BRANDS INC]
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NDC 20276-554-01, 20276-554-04
Set ID 4d24da8e-1eb3-20ca-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Delta Brands Inc
Generic Name
Product Class
Product Number
Application Number PART355
  • Active ingredient

    Sodium monofluorophosphate 0.76% (Total fluoride content-1000 ppm approx.)

  • Purpose

    Anticavity

  • Use

    regular brushing with fluoride toothpaste helps protect teeth against cavities

  • Keep out of the reach of children

    under 6 years of age

  • Warnings

    In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    adults and children 2 yrs and older brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physician. children under 6 yrs to minimize swallowing use a pea-sized amount and brushing until good habits are established. children under 2 years: ask a dentist or physician

  • Inactive ingredients

    calcium carbonate, flavor, polyethylene glycol 400, potassium sorbate, precipitated silica, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, tetra sodium pyrophosphate, titanium dioxide, water

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPER SOFT  ANTI CAVITY
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-554
    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)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-554-012 in 1 BOX03/31/2017
    1NDC:20276-554-04113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/31/2017
    Labeler - Delta Brands Inc (102672008)

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