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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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

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

(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.

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

For dental use only

label

HEA YANTOOTHPASTE 
precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0008
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.09 g  in 100 g
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE37 g  in 100 g
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE0.09 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.09 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73065-0008-1130 g in 1 TUBE; Type 0: Not a Combination Product04/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/24/2023
Labeler - WOORI LIFE & HEALTH (694860803)
Registrant - WOORI LIFE & HEALTH (694860803)
Establishment
NameAddressID/FEIBusiness Operations
WOORI LIFE & HEALTH694860803manufacture(73065-0008) , label(73065-0008)

Revised: 4/2023
Document Id: fa0ab7bf-406a-4c67-e053-6394a90ae7d7
Set id: fa0ab7bf-4069-4c67-e053-6394a90ae7d7
Version: 1
Effective Time: 20230423
 
WOORI LIFE & HEALTH