Cloveden Sensitive Care Tooth — v1

Cloveden Sensitive Care Tooth

4 Views

Version

v1

Effective date

September 26, 2025

Original packager

Yes

Sections captured

10

Identifiers

Document ID
3fb153f1-ba6f-7251-e063-6294a90abe62
Set ID
3fb153f1-ba6e-7251-e063-6294a90abe62
Application numbers
M021
Product NDCs
73242-1113
Package NDCs
73242-1113-1, 73242-1113-2
Original packager NDCs

Names & Manufacturers

Brand names
Cloveden Sensitive Care Tooth
Generic names
SODIUM FLUORIDE
Manufacturer names
DONG IL PHARMS CO.,LTD
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
SODIUM FLUORIDE
Routes
ORAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
8ZYQ1474W7
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient(s) Sodium Fluoride 0.221%
Dosage And Administration (1)

Sequence 1

Directions ■ Apply an appropriate amount to a toothbrush twice a day (morning and evening) and brush your teeth by brushing.
Inactive Ingredient (1)

Sequence 1

Inactive ingredients Sorbitol, Hydrated Silica, Water, Hydroxyapatite, Potassium Nitrate, Glycerin, Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Methyl Cocoyl Taurate, Xylitol, Menthol, Stevioside, Mentha Pulegium Oil, Mentha Piperita Oil, Cooling Flavor, Mint Flavor, Sodium Chloride, Clove Mint Flaovr, Tocopheryl Acetate, Eugenia Caryophyllus (Clove) Flower Oil, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Calendula Officinalis Flower Extract
Indications And Usage (1)

Sequence 1

Use(s) ■ Protection of sensitive teeth ■ Removal of plaque (anti-prag) ■ Prevention of Tooth decay by Fluoride ■ Keep your teeth white and strong ■ Keep your mouth clean ■ Refresh the inside of the mouth ■ Removes bad breath ■ Increases aesthetic effect
Keep Out Of Reach Of Children (1)

Sequence 1

If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.
Other Safety Information (1)

Sequence 1

Other Information ■ Airtight container, Store in room temperature (1~30℃)
Package Label Principal Display Panel (1)

Sequence 1

Carton Image
Purpose (1)

Sequence 1

Purpose Anti-cavity
Spl Product Data Elements (1)

Sequence 1

Cloveden Sensitive Care Tooth Sodium Fluoride TRIBASIC CALCIUM PHOSPHATE WATER SORBITOL SODIUM FLUORIDE FLUORIDE ION
Warnings (1)

Sequence 1

Warnings ■ Do not do the following while using this products Do not use it except for brushing teeth. ■ Other precautions to be taken when using non-medical products 1) The fluoride content of this toothpaste is 1,000 ppm (the total content must be 1,000 ppm or less). 2) If used by children under the age of six, use a small amount of toothpaste about the size of peas per use, and have it used under the guidance of a guardian to prevent washing or swallowing. 3) If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately. ■ Storage precautions 1) Store out of reach of children under the age of six. 2) Remove the non-drug from the original container and store it in another container, which can cause accidents or poor product quality due to misuse, so put it in the original container and keep it closed tightly.

OpenFDA raw payload

{'application_number': ['M021'],
 'brand_name': ['Cloveden Sensitive Care Tooth'],
 'generic_name': ['SODIUM FLUORIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['DONG IL PHARMS CO.,LTD'],
 'package_ndc': ['73242-1113-1', '73242-1113-2'],
 'product_ndc': ['73242-1113'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['ORAL'],
 'spl_id': ['3fb153f1-ba6f-7251-e063-6294a90abe62'],
 'spl_set_id': ['3fb153f1-ba6e-7251-e063-6294a90abe62'],
 'substance_name': ['SODIUM FLUORIDE'],
 'unii': ['8ZYQ1474W7']}