SPL v1
SPL
SPL Set ID 41198822-7c8f-ceb2-e063-6394a90a4373
Route
ORAL
Published
Effective Date 2025-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (7 g) Hydrogen Peroxide (2.14 g)
Inactive Ingredients
Xanthan Gum Citric Acid Peg-32 Sodium Citrate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-07-01

Description

Active ingredient(s) Hydrogen Peroxide 2.14% Silica 7%


Medication Information

Warnings and Precautions

Warnings

• Keep out of reach of children under 6 years of age.

• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Use(s)

• Teeth whitening.

• Remove dental plaque (anti-prag).

• Keep your teeth white and strong.

• Keeps the oral cavity clean.

• Refreshes the oral cavity.

• Prevents cavities and eliminates bad breath.

• Enhance the aesthetic effect.

Dosage and Administration

Directions

• Adults and children 2 years of age and older : Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

• Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

• Children under 2 years : Ask a dentist or physician

Description

Active ingredient(s) Hydrogen Peroxide 2.14% Silica 7%

Section 50565-1

Keep out of reach of children under 6 years of age.

Section 51727-6

Inactive ingredients

Glycerin, PEG-32, Xanthan gum, Citric Acid, Sodium Citrate, Disodium Pyrophosphate, Sodium metaphosphate, Disodium EDTA, Stevioside, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Chaenomeles Sinensis Fruit Extract, Leontopodium Alpinum Extract, Menthol, Mentha Pulegium Oil, Peach Mint Flavor, Honey Peach Flavor, Poloxamer 407, Sodium Lauryl Sulfate, Water

Section 51945-4

Section 53413-1

Questions

+82-1588-9709

Section 55105-1

Purpose

Whitening, Anti-plaque

Section 55106-9

Active ingredient(s)

Hydrogen Peroxide 2.14%

Silica 7%

Section 60561-8

Other Information

• Store at temperatures between 1°C and 30°C

• Use within 36 months from the date of manufacture

• Do not store in high/low temperatures or direct sunlight


Structured Label Content

Indications and Usage (34067-9)

Use(s)

• Teeth whitening.

• Remove dental plaque (anti-prag).

• Keep your teeth white and strong.

• Keeps the oral cavity clean.

• Refreshes the oral cavity.

• Prevents cavities and eliminates bad breath.

• Enhance the aesthetic effect.

Dosage and Administration (34068-7)

Directions

• Adults and children 2 years of age and older : Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

• Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

• Children under 2 years : Ask a dentist or physician

Warnings and Precautions (34071-1)

Warnings

• Keep out of reach of children under 6 years of age.

• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.

Section 51727-6 (51727-6)

Inactive ingredients

Glycerin, PEG-32, Xanthan gum, Citric Acid, Sodium Citrate, Disodium Pyrophosphate, Sodium metaphosphate, Disodium EDTA, Stevioside, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Chaenomeles Sinensis Fruit Extract, Leontopodium Alpinum Extract, Menthol, Mentha Pulegium Oil, Peach Mint Flavor, Honey Peach Flavor, Poloxamer 407, Sodium Lauryl Sulfate, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

+82-1588-9709

Section 55105-1 (55105-1)

Purpose

Whitening, Anti-plaque

Section 55106-9 (55106-9)

Active ingredient(s)

Hydrogen Peroxide 2.14%

Silica 7%

Section 60561-8 (60561-8)

Other Information

• Store at temperatures between 1°C and 30°C

• Use within 36 months from the date of manufacture

• Do not store in high/low temperatures or direct sunlight


Advanced Ingredient Data


Raw Label Data

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