Dentalclean Sensitive Plus

Dentalclean Sensitive Plus
SPL v1
SPL
SPL Set ID 17e0dc93-97bf-7f05-e063-6294a90a9a8b
Route
DENTAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg)
Inactive Ingredients
Sucralose Cetylpyridinium Chloride Anhydrous Sodium Lauryl Sulfate Water Silicon Dioxide Sorbitol Potassium Citrate Carboxymethylcellulose Sodium, Unspecified Form Glycerin Sodium Benzoate Titanium Dioxide Sodium Pyrophosphate Limonene, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-01

Description

Sodium fluoride 0.24%


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 0.24%

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 0.24%

Section 60561-8

Store in a dry, cool place away from sunlight.

Directions

  • Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

• Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.

• Children under 2 years of age: do not use unless directed by a dentist or doctor or as directed by a dentist or doctor.

Inactive Ingredients

Glycerin, Water, Silica, Sodium Lauryl Sulfate, Potassium Citrate Monohydrate, Sorbitol, Aroma, Carmellose Sodium, Tetrasodium Pyrophosphate, Titanium Dioxide, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, 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 0.24%

Section 60561-8 (60561-8)

Store in a dry, cool place away from sunlight.

Directions

  • Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

• Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.

• Children under 2 years of age: do not use unless directed by a dentist or doctor or as directed by a dentist or doctor.

Inactive Ingredients

Glycerin, Water, Silica, Sodium Lauryl Sulfate, Potassium Citrate Monohydrate, Sorbitol, Aroma, Carmellose Sodium, Tetrasodium Pyrophosphate, Titanium Dioxide, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, D-Limonene.


Advanced Ingredient Data


Raw Label Data

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