Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f9bf72cb-56af-a128-e053-6394a90a3cb8
Route
DENTAL
Published
Effective Date 2023-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (3.75 g) Fluoride Ion (0.76 g) Cetylpyridinium (0.3 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-04-20

Description

Sodium monofluorophosphate, Cetylpyridinium chloride, Potassium nitrate


Medication Information

Warnings and Precautions

■ This toothpaste contains 1,000 ppm of fluoride

■ When used for children under the age of 6, use a very

small amount of toothpaste while teaching them not to

suck or swallow it

■ If a large amount is swallowed by a child under the age

of 6, consult a doctor or a dentist immediately

■ Keep out of reach of children under the age of 6

Indications and Usage

Brush your teeth with a suitable amount

Dosage and Administration

dental use only

Description

Sodium monofluorophosphate, Cetylpyridinium chloride, Potassium nitrate

Section 50565-1

keep out of reach of the children

Section 51727-6

Sodium benzoate, Glycerin, Glycyrrhizin acid, Sodium

Copper Chlorophyllin, Sodium lauroyl sarcosinate, Menthol,

Myrrh tincture, Amorphous sorbitol solution(70%),

Saccharin sodium hydrate, Titanium dioxide, Sulfur, Sesin

Ext., Sage Ext., Mugwort Ext., Ascorbic acid, Titrated Ext.

of the unsaponifiable fraction of Zea mays L., Grapefruit

Seed Ext., Xylitol, Purified water, Carboxymethyl Cellulose

sodium, Chmomilla Extract, Bicarbonate sodium, Tocopheryl

acetate, Polyethylene glycol 1500, Propolis Ext.,

Pyrophosphate sodium, Pyridoxine Hydrochloride,

Hydroxyapatite, TIXOSIL 43K, Fragrance

Section 51945-4

Section 55105-1

■ Prevention and reduction of tooth pain

■ Protection of sensitive teeth (tooth pain)

■ Tooth decay prevention

■ Dental plaque removal (anti-plaque)

■ Prevention of gingivitis and periodontitis

■ Keeping teeth white and strong

■ Keeping the inside of the mouth clean

■ Aesthetic effect

Section 55106-9

Sodium monofluorophosphate, Cetylpyridinium chloride, Potassium nitrate


Structured Label Content

Indications and Usage (34067-9)

Brush your teeth with a suitable amount

Dosage and Administration (34068-7)

dental use only

Warnings and Precautions (34071-1)

■ This toothpaste contains 1,000 ppm of fluoride

■ When used for children under the age of 6, use a very

small amount of toothpaste while teaching them not to

suck or swallow it

■ If a large amount is swallowed by a child under the age

of 6, consult a doctor or a dentist immediately

■ Keep out of reach of children under the age of 6

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Sodium benzoate, Glycerin, Glycyrrhizin acid, Sodium

Copper Chlorophyllin, Sodium lauroyl sarcosinate, Menthol,

Myrrh tincture, Amorphous sorbitol solution(70%),

Saccharin sodium hydrate, Titanium dioxide, Sulfur, Sesin

Ext., Sage Ext., Mugwort Ext., Ascorbic acid, Titrated Ext.

of the unsaponifiable fraction of Zea mays L., Grapefruit

Seed Ext., Xylitol, Purified water, Carboxymethyl Cellulose

sodium, Chmomilla Extract, Bicarbonate sodium, Tocopheryl

acetate, Polyethylene glycol 1500, Propolis Ext.,

Pyrophosphate sodium, Pyridoxine Hydrochloride,

Hydroxyapatite, TIXOSIL 43K, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ Prevention and reduction of tooth pain

■ Protection of sensitive teeth (tooth pain)

■ Tooth decay prevention

■ Dental plaque removal (anti-plaque)

■ Prevention of gingivitis and periodontitis

■ Keeping teeth white and strong

■ Keeping the inside of the mouth clean

■ Aesthetic effect

Section 55106-9 (55106-9)

Sodium monofluorophosphate, Cetylpyridinium chloride, Potassium nitrate


Advanced Ingredient Data


Raw Label Data

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