G.U.M (SODIUM FLUORIDE,CETYLPYRIDINIUM CHLORIDE) PASTE [SUNSTAR GUANGZHOU LTD.]

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G.U.M (SODIUM FLUORIDE,CETYLPYRIDINIUM CHLORIDE) PASTE [SUNSTAR GUANGZHOU LTD.]
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NDC 53050-002-01, 53050-002-02, 53050-002-03, 53050-002-04
Set ID 4b537e5c-367f-17d3-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Sunstar Guangzhou Ltd.
Generic Name
Product Class
Product Number
Application Number PART356
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  • Active Ingredient

    SODIUM FLUORIDE 0.21%

    CETYLPYRIDINIUM CHLORIDE 0.5%

  • Purpose

    Anticavitytoothpaste

  • Use

    aids in the prevention of dental decay

  • Warning

    Keep out of 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.

  • Directions

    Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

    do not swallow

    to minimize swallowing use a pea-sized amount in children under 6

    supervise children's burshing ntil good habits are established

    children under 2 years ask a dentist

  • Inactive Ingredients

    WATER,SORBITOL,XANTHAN GUM,SODIUM SILICATE,TRIPOTASSIUM GLYCYRRHIZINATE,PROPYLENE GLYCOL DIACETATE,SODIUM LAURYL SULFATE,CELLULOSE ACETATE,TITANIUM DIOXIDE,CETYLPYRIDINIUM CHLORIDE,SACCHARIN SODIUM,CETYL HYDROXYETHYLCELLULOSE (350000 MW),GLYCERIN

  • 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
    G.U.M 
    sodium fluoride,cetylpyridinium chloride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53050-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL DIACETATE (UNII: 5Z492UNF9O)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CELLULOSE ACETATE (UNII: 3J2P07GVB6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIPOTASSIUM GLYCYRRHIZINATE (UNII: LD4YKZ48B6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53050-002-013 g in 1 TUBE; Type 0: Not a Combination Product03/23/2017
    2NDC:53050-002-026 g in 1 TUBE; Type 0: Not a Combination Product03/23/2017
    3NDC:53050-002-039 g in 1 TUBE; Type 0: Not a Combination Product03/23/2017
    4NDC:53050-002-0414 g in 1 TUBE; Type 0: Not a Combination Product03/23/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/10/2016
    Labeler - Sunstar Guangzhou Ltd. (544725724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sunstar Guangzhou Ltd.544725724manufacture(53050-002)
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