APPATOTTOOTHPASTE- precipitated calcium carbonate paste, dentifrice

AppatotToothpaste by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Calcium Carbonate

PURPOSE

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

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

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

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APPATOTTOOTHPASTE 
precipitated calcium carbonate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73065-0011
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEPPERMINT OIL (UNII: AV092KU4JH)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73065-0011-1	180 g in 1 TUBE; Type 0: Not a Combination Product	01/17/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/17/2024

Labeler - WOORI LIFE & HEALTH (694860803)

Registrant - WOORI LIFE & HEALTH (694860803)

Establishment
Name	Address	ID/FEI	Business Operations
WOORI LIFE & HEALTH		694860803	manufacture(73065-0011) , label(73065-0011)