Label: SMILECARE- 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 14, 2014

If you are a consumer or patient please visit this version.

View All Sections
  • INACTIVE INGREDIENT

    Inactive Ingredients: Dicalcium Phosphate, Water, Sorbitol, Silica, Glycerin,

    Sodium Lauryl Sulfate, Flavor, Sodium Carboxymethyl Cellulose, Titanium Dioxide,

    Hydroxypropyl Gum, Sodium Saccharine, Sodium Benzoate, Sodium Phosphate

    Decahydrate, Limonene, Contains Sodium Monoflourophosphate: 1.0556ppm

  • ACTIVE INGREDIENT

    Active Ingredient: Sodium Monofluorophosphate 0.080 %

  • PURPOSE

    Purpose: Anticavity toothpaste

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 yrs.

  • WARNINGS

    Do not swallow

  • DOSAGE & ADMINISTRATION

    Directions: Brush your teeth at least twice a day as directed by dentist.

  • INDICATIONS & USAGE

    Anticavity toothpaste

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SMILECARE  
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69108-001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION64 mg  in 8 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69108-001-018 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2014
    Labeler - Shantou MContinents Trading Co, LTD (421359546)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shantou MContinents Trading Co, LTD421359546manufacture(69108-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!