HEA YANTOOTHPASTE- precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste, dentifrice

Hea YanToothpaste by

Drug Labeling and Warnings

Hea YanToothpaste by is a Otc medication manufactured, distributed, or labeled by WOORI LIFE & HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Precipitated Calcium Carbonate
Aluminum Chlorohydroxy Allantoinate
Aminocaproic Acid
Dibasic Calcium Phosphate Hydrate

PURPOSE

To be white and strong, Maintain and clean the mouth, Refresh the oral cavity, Prevention of tooth decay, eliminates bad breat, Enhances the aesthetic effect, Periodontitis (pyorrhea) the prevention, gum disease prevention, Prevention of gingivitis, periodontal disease prevention, gingiva diseage prevention, plaque removal (anti-plaque).

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

WARNINGS

(1) Do not swallow, gargle fully after using.
(2) If the use of this paste causes gingiva or oral cavity injury, please stop using and consult a doctor or a dentist.
(3) If childern under 6 years of age use, please apply a pea-sized amount each thime. Do not swallow. Please use under the guidance of the guardian.
(4) If children under 6 years of age accidentally ingest large amounts of the paste, please consult a doctor or a dentist immediately.
(5) Keep out of reach of children under 6 years of age.

INACTIVE INGREDIENT

D-Sorbitol Solution
Glycerin
Silica
Roasted salt
Xanthan Gum
Carboxymethylcellulose Sodium
Sodium Lauryl Sulfate
Graperuit seed extract
Sodium Saccharin
xylitol
L-Menthol
Green tea extract
Propolis Extract
Glycyrrhiza Extract
Mulberry Root Extract
Peppermint oil
Purified Water in Bulk

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEA YANTOOTHPASTE 
precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73065-0008
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.09 g  in 100 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	37 g  in 100 g
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	0.09 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2)	ALCLOXA	0.09 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: 73065-0008-1	130 g in 1 TUBE; Type 0: Not a Combination Product	04/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/24/2023

Labeler - WOORI LIFE & HEALTH (694860803)

Registrant - WOORI LIFE & HEALTH (694860803)

Establishment
Name	Address	ID/FEI	Business Operations
WOORI LIFE & HEALTH		694860803	manufacture(73065-0008) , label(73065-0008)