TROPICAL MINT DENTISTRY (SODIUM FLUORIDE) PASTE [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]

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TROPICAL MINT DENTISTRY (SODIUM FLUORIDE) PASTE [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]
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NDC 71035-902-01, 71035-902-02
Set ID 726b8e28-3299-67b9-e053-2a91aa0ad1fe
Category HUMAN OTC DRUG LABEL
Packager Yangzhou Hongshengding Chemical Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART356
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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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