Label: WESTERN DENTAL- sodium fluoride paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 June 19, 2017

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  • Active ingredients

    SODIUM MONOFLUOROPHOSPHATE 0.76%

    Purpose

    anticavity toothpaste

  • Uses

    Aids in the prevention of dental cavities

  • Warnings

    Keep out of the reach of children under 6 years of age.if more than used for brushing is accidentally swalowed, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

  • Directions

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

    Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing),

    supervise children as necessary until capable of useing without supervision.Children under 2 years of age:consult a dentist or doctor.

  • INACTIVE INGREDIENT

    calcium carbonate,CarboxyMethyl Cellulose ,glycerin,hydrated silica,purified water,Sodium Benzoate,Sodium Lauryl Sulfate,Sodium Saccharin,Sorbitol,Tetrasodium Diphosphate

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    WESTERN DENTAL 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-800
    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 LAURYL SULFATE (UNII: 368GB5141J)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    PHYTONADIOL TETRASODIUM DIPHOSPHATE (UNII: X952T8E4RN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71035-800-016 in 1 CARTON02/11/2016
    124 in 1 BOX
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/11/2016
    Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-800)
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