GLORYSMILE TOOTHPASTE.- glorysmile toothpaste cream 
LLRN PERSONAL CARE(SHENZHEN)CO., LTD

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.

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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

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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)

Revised: 11/2023
Document Id: 0addc66f-2dfd-66ed-e063-6394a90a3513
Set id: 0addc66f-2dfc-66ed-e063-6394a90a3513
Version: 1
Effective Time: 20231123
 
LLRN PERSONAL CARE(SHENZHEN)CO., LTD