dentalclean doctor duck strawberry kids flouride mouthwash

dentalclean doctor duck strawberry kids flouride mouthwash
SPL v1
SPL
SPL Set ID 1882c82a-3a32-5656-e063-6394a90ae0ed
Route
dental
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 mg)
Inactive Ingredients
sucralose cetylpyridinium chloride anhydrous tetrasodium edetate dihydrate water sodium phosphate, monobasic, monohydrate sorbitol fd&c blue no. 1 sodium benzoate sodium phosphate dibasic dihydrate limonene, (+/-)- polyoxyl 60 hydrogenated castor oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-01

Description

Sodium fluoride 0.02%


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 0.02%

Indications and Usage

Use aids in the prevention of dental cavities

Directions

Children of 6 years of age and older:

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

•Remove cap

• Hold bottle upright and squeeze

•Pour out

•Vigorously swish between your teeth for 1 minute and then spit out

• Do not swallow the rinse.

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

• Supervise children as necessary until capable of using without supervision.

• Children under 6 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, Sorbitol, Ethoxylated Hydrogenated Ricin Oil, Fragrance, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Brilliant Blue (CI 42090), D-Limonene.

Description

Sodium fluoride 0.02%

Section 50565-1

Keep out of reach of children under 6 years of age

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 0.02%

Indications and Usage (34067-9)

Use aids in the prevention of dental cavities

Directions

Children of 6 years of age and older:

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

•Remove cap

• Hold bottle upright and squeeze

•Pour out

•Vigorously swish between your teeth for 1 minute and then spit out

• Do not swallow the rinse.

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

• Supervise children as necessary until capable of using without supervision.

• Children under 6 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, Sorbitol, Ethoxylated Hydrogenated Ricin Oil, Fragrance, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Brilliant Blue (CI 42090), D-Limonene.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age

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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