Label: TROPICAL MINT DENTISTRY- 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 September 7, 2018

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  • Active ingredients

    Sodium Fluoride 0.24%

    Purpose

    anticavity

  • Uses

    aids in the prevention of dental vavities.

  • Warnings

    Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,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 doctor.

    Instruct Children under 6 years of age in good burshing and rinsing ahnbits(to mininize swallowing ).supervise children as necessary until catlble of using without supervision.

    Children under 2 years:Consult a dentist or doctor.

  • INACTIVE INGREDIENT

    HYDRATED SILICA,HYDROXYETHYL CELLULOSE,WATER,CARBOXYMETHYLCELLULOSE,SACCHARIN SODIUM,SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS.SODIUM BENZOATE,SODIUM LAURYL SULFATE,SORBITOL,GLYCERIN

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    TROPICAL MINT DENTISTRY 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71035-902
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    HYDROXYETHYL CELLULOSE (40 MPA.S AT 2%) (UNII: I2N4ZF9233)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71035-902-0172 in 1 CARTON09/04/2016
    11 in 1 BOX
    1170.1 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:71035-902-02288 in 1 CARTON09/04/2016
    21 in 1 BOX
    228.35 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 finalpart35609/04/2016
    Labeler - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Registrant - Yangzhou Hongshengding Chemical Co.,Ltd. (543774755)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yangzhou Hongshengding Chemical Co.,Ltd.543774755manufacture(71035-902)
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