Label: IDODENT FLOURIDE MINT- fluoride 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 November 24, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                                                 Purpose

    Sodium monofluorophosphate 0.76%---------------------------------------------------- Anticavity

    (Total Fluoride Content - 1000 ppm Approx.)

  • PURPOSE

    Uses

    Regular brushing with fluoride toothpaste helps protect teeth and roots against cavities

  • WARNINGS

    Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Warnings

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

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

  • INDICATIONS & USAGE

    Directions

     Adults and children 2 years and older Brush Teeth thoroughly after meals, twice a day, or use as directed by a dentist or physician.
     Children under 6 years To minimize swallowing use a pea-sized amount and supervise brushing until good habits are established.
     Children under 2 years Ask a dentist or physician.

  • STORAGE AND HANDLING

    Other Information

    Store at room temperature 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    calcium carbonate, water, sorbitol, hydrated silica, sodium lauryl sulfate, flavor, cellulose gum, sodium silicate, tetrasodium, propphosphate, sodium saccharin, titanium dioxide, methylparaben, PEG-8, propylparaben

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    10101A

  • INGREDIENTS AND APPEARANCE
    IDODENT FLOURIDE MINT 
    fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-181
    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
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-181-181 in 1 CARTON12/21/201610/13/2021
    1181 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/23/2014
    Labeler - United Exchange Corp. (840130579)
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