Label: GLORYSMILE TOOTHPASTE. cream

  • NDC Code(s): 83778-005-02
  • Packager: Nanchang Dental Bright Technology Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 29, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Sodium Fluoride 0.1%

    Sodium Gluconate 0.1%

  • Purpose

    Teeth cleaning

  • Use

    temporarily clean and whiten teeth.

  • Warnings

    Product is not intended for use by children.
    Do not swallow. Do not use in eye area.

  • When Using

    Do not swallow. Do not use in eye area

    keep out of reach of young children.

  • Directions

    Apply toothpaste to toothbrush.

    Brush for 2 minutes.

    Expel excess toothpaste

  • Other Information

    please keep in dry and cool place

  • Inactive ingredients

    Aqua(Water),Sorbitol, Hydrated Silica, Xylitol,Glycerin, Aroma(Flavour), Disodium Phosphate.Sodium Lauroyl Sarcosinate, CalciumGlycerophosphate, Cellulose Gum, XanthanGum, Tetrapotassium Pyrophosphate.Benzyl Alcohol, Caprylyl Glycol, Sucralose, Menthol.Pentylene Glycol, Zinc Lactate, MethylDiisopropyl Propionamide, Benzoic Acid

  • Keep Oot Of Reach Of Children

    Please place it out of the reach of children

  • PRINCIPAL DISPLAY PANEL

    1234

  • INGREDIENTS AND APPEARANCE
    GLORYSMILE TOOTHPASTE. 
    glorysmile toothpaste. cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83778-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.1 g  in 100 g
    SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM GLUCONATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    MENTHOL (UNII: L7T10EIP3A)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83778-005-0260 g in 1 BOTTLE; Type 0: Not a Combination Product11/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/19/2023
    Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanchang Dental Bright Technology Co.,Ltd.544503502label(83778-005) , manufacture(83778-005)