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.



Indications and Usage

Use aids in the prevention of dental cavities

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 55106-9

Sodium fluoride 0.02%

Section 60561-8

Store in a dry, cool place away from sunlight.

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.

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 under 6 years of age

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium fluoride 0.02%

Section 60561-8 (60561-8)

Store in a dry, cool place away from sunlight.

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.810135 · Updated: 2026-03-14T23:03:01.087200