GLORYSMILE TOOTHPASTE. paste, dentifrice

Glorysmile Toothpaste. by

Drug Labeling and Warnings

Glorysmile Toothpaste. by is a Otc medication manufactured, distributed, or labeled by Jiangxi Dentalbright Technology Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Teeth cleaning

Active Ingredient

Sodium Fluoride

Sodium Gluconate

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

1. Apply 2 pumps to a soft bristle toothbrush.
2. Gently brush it a circular motion for 2 minutes.
3. Expel excess and rinse mouth after use, do not swallow.

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

INGREDIENTS AND APPEARANCE

GLORYSMILE TOOTHPASTE. 
glorysmile toothpaste. paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83778-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.25 g  in 100 g
SODIUM GLUCONATE (UNII: R6Q3791S76) (GLUCONIC ACID - UNII:R4R8J0Q44B)	SODIUM GLUCONATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ZINC LACTATE (UNII: 2GXR25858Y)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITOL (UNII: 506T60A25R)
DISODIUM PHOSPHATE (UNII: 22ADO53M6F)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TETRAPOTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
XYLITOL (UNII: VCQ006KQ1E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83778-010-01	60 g in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	10/24/2023

Labeler - Jiangxi Dentalbright Technology Co., Ltd (544503502)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Dentalbright Technology Co., Ltd		544503502	manufacture(83778-010)