SPL v1
SPL
SPL Set ID fa8561f3-449c-ce22-e053-6294a90a6435
Route
DENTAL
Published
Effective Date 2023-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (2.14 g) .alpha.-tocopherol (0.2 g) Silicon Dioxide (7 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-04-24

Description

Hydrogen peroxide, Tocopheryl acetate, silicon dioxide


Medication Information

Warnings and Precautions

(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.

Indications and Usage

apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

Dosage and Administration

For dental use only

Description

Hydrogen peroxide, Tocopheryl acetate, silicon dioxide

Section 50565-1

Keep out of reach of children

Section 51727-6

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

Section 51945-4

Section 55105-1

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)

Section 55106-9

Hydrogen peroxide, Tocopheryl acetate, silicon dioxide


Structured Label Content

Indications and Usage (34067-9)

apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

(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.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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)

Section 55106-9 (55106-9)

Hydrogen peroxide, Tocopheryl acetate, silicon dioxide


Advanced Ingredient Data


Raw Label Data

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