Label: APPATOTTOOTHPASTE- precipitated calcium carbonate paste, dentifrice
- NDC Code(s): 73065-0011-1
- Packager: WOORI LIFE & HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated January 16, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
APPATOTTOOTHPASTE
precipitated calcium carbonate paste, dentifriceProduct 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)