SPL v1
SPL
SPL Set ID dbf92ddf-ffc6-be65-e053-2995a90acfaa
Route
DENTAL
Published
Effective Date 2022-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (2.296 g)
Inactive Ingredients
Xylitol Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-04-06

Description

Cetylpyridinium chloride


Medication Information

Warnings and Precautions

1.Do not store it above 30°C2. Avoid exposure to heat, sparks and flames3. Be careful as it can irritate your eyes4.Wash with water when contacting eyes5. Store out of reach of infants and children

Indications and Usage

Three times a day, put 5 drops of the concentrated solution into a sealed cup, addwater to the marked line, brush your teeth (gargle) with dilute solution for about 30seconds, and spit it out

Dosage and Administration

For dental use only

Description

Cetylpyridinium chloride

Section 50565-1

Keep out of reach of children

Section 51727-6

Concentrated Glycerin

D-Sorbitol Solution

Propolis Extract

Chitosan

Grapefruit Seed Extract

Green Tea Extract

Eucalyptus Extract

Matricaria Extract

Steviol Glycoside

Xylitol

Peppermint Flavor

Gardenia Blue

Sodium Bicarbonate

Water

Section 51945-4

Section 55105-1

Clean mouth, remove plaque, clean mouth, remove odors

Section 55106-9

Cetylpyridinium chloride


Structured Label Content

Indications and Usage (34067-9)

Three times a day, put 5 drops of the concentrated solution into a sealed cup, addwater to the marked line, brush your teeth (gargle) with dilute solution for about 30seconds, and spit it out

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

1.Do not store it above 30°C2. Avoid exposure to heat, sparks and flames3. Be careful as it can irritate your eyes4.Wash with water when contacting eyes5. Store out of reach of infants and children

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Concentrated Glycerin

D-Sorbitol Solution

Propolis Extract

Chitosan

Grapefruit Seed Extract

Green Tea Extract

Eucalyptus Extract

Matricaria Extract

Steviol Glycoside

Xylitol

Peppermint Flavor

Gardenia Blue

Sodium Bicarbonate

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Clean mouth, remove plaque, clean mouth, remove odors

Section 55106-9 (55106-9)

Cetylpyridinium chloride


Advanced Ingredient Data


Raw Label Data

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