Label: GLORYSMILE TOOTHPASTE.- glorysmile toothpaste cream

  • NDC Code(s): 83812-003-01
  • Packager: LLRN PERSONAL CARE(SHENZHEN)CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 23, 2023

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  • Active Ingredient

    Sodium Fluoride 0.1%

    Sodium Gluconate 0.1%

  • Purpose

    teeth cleaning, anti-sensitivity

  • Use

    Those who want to clean and whiten their teeth.

  • Warnings

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

  • Do not use

    Product is not intended for use by children.

  • When Using

    Do not swallow. Do not use in eye area.

  • Stop Use

    If there is any discomfort, please stop using.

  • Ask Doctor

    If there is any discomfort, please consult a dentist immediately

  • Keep Oot Of Reach Of Children

    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、Calcium Glycerophosphate、Cellulose Gum、Xanthan Gum、Tetrapotassium Pyrophosphate、Benzyl Alcohol、Caprylyl Glycol、Sucralose、Menthol、Pentylene Glycol、Zinc Lactate、Methyl Diisopropyl Propionamide、Benzoic Acid

  • PRINCIPAL DISPLAY PANEL

    1234

  • INGREDIENTS AND APPEARANCE
    GLORYSMILE TOOTHPASTE. 
    glorysmile toothpaste cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83812-003
    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
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83812-003-0160 g in 1 BOTTLE; Type 0: Not a Combination Product11/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/23/2023
    Labeler - LLRN PERSONAL CARE(SHENZHEN)CO., LTD (419890311)
    Establishment
    NameAddressID/FEIBusiness Operations
    LLRN PERSONAL CARE(SHENZHEN)CO., LTD419890311manufacture(83812-003) , label(83812-003)
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