APPATOTTOOTHPASTE- precipitated calcium carbonate 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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Calcium Carbonate

Tooth whitening, tooth decay prevention, bad breath removal. Makes tooth strong.

Keeps the mouth clean, Refreshes the inside of the mouth. lncreases the aesthetic effect. Prevention of periodontal disease, gum disease and, removal of plaque (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.

Tocopheryl Acetate
Aluminum Chlorohydroxy Allantoinate
Dibasic Calcium Phosphate Hydrate
D-Sorbitol Solution
Glycerin
Silica
Carboxymethylcellulose Sodium
Chitosan
Cocamidopropyl Betaine
Steviol Glycoside
Xylitol
L-Menthol
Aloe Extract(09)
Grapefruit Seed Extract
Green Tea Extract
Glycyrrhiza Extract
Morinda Citrifolia Extract
Sage Extract
Propolis Extract
Lemon oil
Peppermint Oil
Pine fravor
Activated carbon
Hydroxyapatite
Purified Water in Bulk

For dental use only

label

APPATOTTOOTHPASTE 
precipitated calcium carbonate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0011
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73065-0011-1180 g in 1 TUBE; Type 0: Not a Combination Product01/17/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/17/2024
Labeler - WOORI LIFE & HEALTH (694860803)
Registrant - WOORI LIFE & HEALTH (694860803)
Establishment
NameAddressID/FEIBusiness Operations
WOORI LIFE & HEALTH694860803manufacture(73065-0011) , label(73065-0011)

Revised: 1/2024
Document Id: 0f1d966f-eb9d-91e3-e063-6394a90a0250
Set id: 0f1d9654-229a-c2e8-e063-6294a90a1dbf
Version: 1
Effective Time: 20240116
 
WOORI LIFE & HEALTH