SPL v1
SPL
SPL Set ID 0f1d9654-229a-c2e8-e063-6294a90a1dbf
Route
DENTAL
Published
Effective Date 2024-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (0.1 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Peppermint Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-01-17

Description

Calcium Carbonate


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

Calcium Carbonate

Section 50565-1

Keep out of reach of children

Section 51727-6

Tocopheryl Acetate

Aluminum Chlorohydroxy Allantoinate

Dibasic Calcium Phosphate Hydrate

D-Sorbitol Solution

Glycerin

Silica

Carboxymethylcellulose Sodium

Chitosan

Cocamidopropyl Betaine

Steviol Glycoside

Xylitol

L-Menthol

Aloe Extract(09)

Grapefruit Seed Extract

Green Tea Extract

Glycyrrhiza Extract

Morinda Citrifolia Extract

Sage Extract

Propolis Extract

Lemon oil

Peppermint Oil

Pine fravor

Activated carbon

Hydroxyapatite

Purified Water in Bulk

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

Calcium Carbonate


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)

Tocopheryl Acetate

Aluminum Chlorohydroxy Allantoinate

Dibasic Calcium Phosphate Hydrate

D-Sorbitol Solution

Glycerin

Silica

Carboxymethylcellulose Sodium

Chitosan

Cocamidopropyl Betaine

Steviol Glycoside

Xylitol

L-Menthol

Aloe Extract(09)

Grapefruit Seed Extract

Green Tea Extract

Glycyrrhiza Extract

Morinda Citrifolia Extract

Sage Extract

Propolis Extract

Lemon oil

Peppermint Oil

Pine fravor

Activated carbon

Hydroxyapatite

Purified Water in Bulk

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)

Calcium Carbonate


Advanced Ingredient Data


Raw Label Data

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