CLOVEDEN SENSITIVE CARE TOOTH- sodium fluoride paste, dentifrice

Cloveden Sensitive Care Tooth by

Drug Labeling and Warnings

Cloveden Sensitive Care Tooth by is a Otc medication manufactured, distributed, or labeled by Acuseplanet Inc, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Sodium Fluoride 0.221%

PURPOSE

Purpose

Anti-cavity

INDICATIONS & USAGE

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

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

Other Information

■ Airtight container, Store in room temperature (1~30℃)

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOVEDEN SENSITIVE CARE TOOTH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84516-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84516-020-02	1 in 1 CARTON	07/01/2024
1	NDC: 84516-020-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/01/2024

Labeler - Acuseplanet Inc (987646711)

Registrant - Acuseplanet Inc (987646711)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(84516-020)