Dentalclean Green Diamond Alcohol Free Mouthwash

Dentalclean Green Diamond Alcohol Free Mouthwash
SPL v1
SPL
SPL Set ID 5653aa33-4f0e-46b2-9be0-6219143556ec
Route
DENTAL
Published
Effective Date 2025-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2 mg)
Inactive Ingredients
Sucralose Cetylpyridinium Chloride Anhydrous Edetate Disodium Water Sodium Phosphate, Monobasic, Monohydrate Sorbitol Fd&c Blue No. 1 Sodium Benzoate Eugenol Sodium Phosphate Dibasic Dihydrate Cinnamaldehyde Yellow 5 Peg-40 Hydrogenated Castor Oil Glycerol Formal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

Description

Sodium fluoride 0.05%


Medication Information

Warnings and Precautions

WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.

Indications and Usage

Use aids in the prevention of dental cavities

Description

Sodium fluoride 0.05%

Section 50565-1

Keep out of reach of children 

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium fluoride 0.05%

Section 60561-8

Store in a dry, cool place away from sunlight.

Directions

Adults and children of 6 years of age and older:

• Use twice a day after brushing your teeth with a toothpaste.

•Remove cap

• Hold bottle upright and squeeze

•Pour out the rinse inside the cap

•Vigorously swish between your teeth for 30 to 60 seconds and then spit out

• Do not swallow the rinse.

• Do not eat or drink for 30 minutes after rinsing.

Inactive Ingredients

Water, Glycerol, PEG-40 Hydrogenated Castor Oil, Sorbitol, Aroma, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Yellow 5 (CI 19140), Blue 1 (CI 42090), Cinnamaldehyde, Eugenol.


Structured Label Content

Indications and Usage (34067-9)

Use aids in the prevention of dental cavities

Warnings and Precautions (34071-1)

WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.

Section 50565-1 (50565-1)

Keep out of reach of children 

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium fluoride 0.05%

Section 60561-8 (60561-8)

Store in a dry, cool place away from sunlight.

Directions

Adults and children of 6 years of age and older:

• Use twice a day after brushing your teeth with a toothpaste.

•Remove cap

• Hold bottle upright and squeeze

•Pour out the rinse inside the cap

•Vigorously swish between your teeth for 30 to 60 seconds and then spit out

• Do not swallow the rinse.

• Do not eat or drink for 30 minutes after rinsing.

Inactive Ingredients

Water, Glycerol, PEG-40 Hydrogenated Castor Oil, Sorbitol, Aroma, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Yellow 5 (CI 19140), Blue 1 (CI 42090), Cinnamaldehyde, Eugenol.


Advanced Ingredient Data


Raw Label Data

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