GLORYSMILE TOOTHPASTE.- glorysmile toothpaste. cream
Nanchang Dental Bright Technology 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

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

GLORYSMILE TOOTHPASTE.
glorysmile toothpaste. cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83778-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.1 g in 100 g
SODIUM GLUCONATE (UNII: R6Q3791S76) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM GLUCONATE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83778-005-02	60 g in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/19/2023

Labeler - Nanchang Dental Bright Technology Co.,Ltd. (544503502)

Name	Address	ID/FEI	Business Operations
Establishment
Nanchang Dental Bright Technology Co.,Ltd.		544503502	label(83778-005) , manufacture(83778-005)