TOOTHPASTETOOTHPASTE (AQUA MINT FLAVOR)- hydrogen peroxide, tocopheryl acetate, silicon dioxide paste, dentifrice

ToothpasteToothpaste (Aqua mint flavor) by

Drug Labeling and Warnings

ToothpasteToothpaste (Aqua mint flavor) by is a Otc medication manufactured, distributed, or labeled by WOORI LIFE & HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrogen peroxide, Tocopheryl acetate, silicon dioxide

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

glycerin

D-Sorbitol solution

Propylene Glycol

Xanthan gum

Carboxymethyl cellulose sodium

Cocovl Glutamate sodium

Xylitol

STEVIOL GLYCOSIDE

Green tea extract

Lycium Chinense Fruit Extract

Mulberry Root Extract

Angelica Gigas Root Extract

Graperuit seed extract

Mugwort Extract

Sponge Cucumber Gourd Extract

Mastic oil

Sodium Phosphate

Citric acid

L-Menthol

Aquamint flavor

peppermint oil

Purified water

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOOTHPASTETOOTHPASTE (AQUA MINT FLAVOR) 
hydrogen peroxide, tocopheryl acetate, silicon dioxide paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73065-0009
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.14 g  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.2 g  in 100 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73065-0009-1	100 mL 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(73065-0009) , label(73065-0009)