GLORYSMILE TOOTHPASTE.- glorysmile toothpaste cream

GlorySmile toothpaste. by

Drug Labeling and Warnings

GlorySmile toothpaste. by is a Otc medication manufactured, distributed, or labeled by LLRN PERSONAL CARE(SHENZHEN)CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

GLORYSMILE TOOTHPASTE. 
glorysmile toothpaste cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83812-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83812-003-01	60 g in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/23/2023

Labeler - LLRN PERSONAL CARE(SHENZHEN)CO., LTD (419890311)

Establishment
Name	Address	ID/FEI	Business Operations
LLRN PERSONAL CARE(SHENZHEN)CO., LTD		419890311	manufacture(83812-003) , label(83812-003)