SPL v1
SPL
SPL Set ID 3fb16579-7cf1-873a-e063-6294a90a9ac1
Route
ORAL
Published
Effective Date 2025-09-26
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
Glycerin Sodium Metaphosphate Water Sodium Cocoyl Glutamate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-08-01

Description

Active ingredient(s) Silica 7.0% Hydrogen Peroxide(35%) 2.14% Tocopheryl Acetate 0.2%


Medication Information

Warnings and Precautions

Warnings

■ Keep out of the 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)

■ Whitens teeth.

■ Prevents cavities and eliminates bad breath.

■ Strengthens teeth.

■ Keeps the oral cavity clean.

■ Refreshes the oral cavity.

■ Enhance the aesthetic effect.

■ Prevention of gingivitis, periodontitis (pyorrhoea).

■ Prevention of periodontal disease.

■ prevention of gum disease.

■ Remove dental plaque (anti-prag)

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) Silica 7.0% Hydrogen Peroxide(35%) 2.14% Tocopheryl Acetate 0.2%

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

Water, Glycerin, Sodium Cocoyl Glutamate, Sodium metaphosphate, Xylitol, Xanthan gum, Menthol, Citrus Limon Fruit Oil, Poloxamer 407, Apple-Chamomile Mint Flavor, Double Mint Flavor, Citric Acid, Sucralose, Cooling Flavor, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Disodium EDTA, Hydroxyapatite, Solanum Lycopersicum Fruit Extract, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis Leaf Extract, Citrus Limon (Lemon) Fruit Extract

Section 51945-4

Section 53413-1

Questions

■ https://acuseplanet.cafe24.com/shop2/

■ Customer center : 070-8065-7737

Section 55105-1

Purpose

Antiplaque

Whitening

Antigingivitis

Section 55106-9

Active ingredient(s)

Silica 7.0%

Hydrogen Peroxide(35%) 2.14%

Tocopheryl Acetate 0.2%

Section 60561-8

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light


Structured Label Content

Indications and Usage (34067-9)

Use(s)

■ Whitens teeth.

■ Prevents cavities and eliminates bad breath.

■ Strengthens teeth.

■ Keeps the oral cavity clean.

■ Refreshes the oral cavity.

■ Enhance the aesthetic effect.

■ Prevention of gingivitis, periodontitis (pyorrhoea).

■ Prevention of periodontal disease.

■ prevention of gum disease.

■ Remove dental plaque (anti-prag)

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 the 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

Section 51727-6 (51727-6)

Inactive ingredients

Water, Glycerin, Sodium Cocoyl Glutamate, Sodium metaphosphate, Xylitol, Xanthan gum, Menthol, Citrus Limon Fruit Oil, Poloxamer 407, Apple-Chamomile Mint Flavor, Double Mint Flavor, Citric Acid, Sucralose, Cooling Flavor, Melaleuca Alternifolia Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Disodium EDTA, Hydroxyapatite, Solanum Lycopersicum Fruit Extract, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis Leaf Extract, Citrus Limon (Lemon) Fruit Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

■ https://acuseplanet.cafe24.com/shop2/

■ Customer center : 070-8065-7737

Section 55105-1 (55105-1)

Purpose

Antiplaque

Whitening

Antigingivitis

Section 55106-9 (55106-9)

Active ingredient(s)

Silica 7.0%

Hydrogen Peroxide(35%) 2.14%

Tocopheryl Acetate 0.2%

Section 60561-8 (60561-8)

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)