TOOTHPASTETOOTHPASTE (AQUA MINT FLAVOR)- hydrogen peroxide, tocopheryl acetate, silicon dioxide 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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Hydrogen peroxide, Tocopheryl acetate, silicon dioxide

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.

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

For dental use only

label

TOOTHPASTETOOTHPASTE (AQUA MINT FLAVOR) 
hydrogen peroxide, tocopheryl acetate, silicon dioxide paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0009
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 g  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73065-0009-1100 mL 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(73065-0009) , label(73065-0009)

Revised: 4/2023
Document Id: fa856208-e7a7-043d-e053-6294a90a4ed9
Set id: fa8561f3-449c-ce22-e053-6294a90a6435
Version: 1
Effective Time: 20230429
 
WOORI LIFE & HEALTH