Label: IODENT TOOTH- 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 February 15, 2022

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  • Active Ingredient

    sodium monofluorphosphate  0.76%

  • Purpose

    Anticavity

  • Use

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

  • Warning

    Keep out of reach under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adults and children 2 years and older brush teeth thoroughly, preferably after each meal or as least twice a day , or as directly by a dentist or doctor

    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 Ingredients

    calcium carbonate , water, sorbitol , silica, polyethylene glycol 400, sodium laury alcohol, sodium carboxymethyl cellulose, flavor, sodium saccharin, methylparaben, propyparaben , sodium hydroxide

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

    Keep out of reach of children under 6 years of age

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    IODENT TOOTH 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72129-001
    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
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SORBITOL (UNII: 506T60A25R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYPERONE (UNII: HG22108KQK)  
    SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72129-001-0124 in 1 BOX02/02/2018
    16 in 1 PACKAGE
    1181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/02/2018
    Labeler - Zhaoqing Longda Biotechnology Co., Ltd. (546452557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhaoqing Longda Biotechnology Co., Ltd.546452557manufacture(72129-001)
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