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.

Active Ingredient

Sodium fluoride 0.05%

Indications and Usage

Use aids in the prevention of dental cavities

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.

Description

Sodium fluoride 0.05%

Section 50565-1

Keep out of reach of children 

Section 51945-4

Section 55105-1

Anticavity

Section 60561-8

Store in a dry, cool place away from sunlight.


Structured Label Content

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.

Active Ingredient (55106-9)

Sodium fluoride 0.05%

Indications and Usage (34067-9)

Use aids in the prevention of dental cavities

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.

Section 50565-1 (50565-1)

Keep out of reach of children 

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 60561-8 (60561-8)

Store in a dry, cool place away from sunlight.


Advanced Ingredient Data


Raw Label Data

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