CLEAN BREATH TOOTH- precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice

CLEAN BREATH TOOTH by

Drug Labeling and Warnings

CLEAN BREATH TOOTH by is a Otc medication manufactured, distributed, or labeled by K.Boeun Pharmaceutical Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

INACTIVE INGREDIENT

Water, D-Sorbitol Solution, Concentrated Glycerin, Silicon Dioxide, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Xanthangum, Mentha Oil, Enzymatically Modified Stevia, Titanium Oxide, Sodium Chloride, Propolis Extract, l-Menthol, Xylitol, Ascorbic Acid, Green Tea Extract, Aloe Extract, Tocopherol Acetate

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

WARNINGS

Warnings

Keep out of reach of children

■ If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other Information

■ Store in an airtight container at room temperature

■ Date of use : 36 months from the date of manufacture

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAN BREATH TOOTH 
precipitated calcium carbonate, dibasic calcium phosphate, aminocaproic acid, aluminium chlorohydroxy allantoinate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74724-0028
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J)	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	0.07 g  in 100 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	36 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2)	ALCLOXA	0.06 g  in 100 g
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.06 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74724-0028-1	180 g in 1 TUBE; Type 0: Not a Combination Product	11/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/30/2021

Labeler - K.Boeun Pharmaceutical Co.,Ltd. (695674074)

Registrant - K.Boeun Pharmaceutical Co.,Ltd. (695674074)

Establishment
Name	Address	ID/FEI	Business Operations
K.Boeun Pharmaceutical Co.,Ltd.		695674074	manufacture(74724-0028)