Dentalclean Regenerator Sensitive Dental Gel With Flouride

Dentalclean Regenerator Sensitive Dental Gel With Flouride
SPL v1
SPL
SPL Set ID 176aa3ed-e2a4-536d-e063-6294a90aa097
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 Menthol Carboxymethylcellulose Glycerol Formal Sodium Benzoate Phosphoric Acid Sodium Pyrophosphate Mica

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 51727-6

Glycerol, Silium Dioxide, Sorbitol, Water, Sodium Lauryl Sulphate, Aroma, Carmelose Sodium, Phoshoric Acid, Tetrassodium Pyrophosphate, Menthol, Mica, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose

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.

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 51727-6 (51727-6)

Glycerol, Silium Dioxide, Sorbitol, Water, Sodium Lauryl Sulphate, Aroma, Carmelose Sodium, Phoshoric Acid, Tetrassodium Pyrophosphate, Menthol, Mica, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose

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.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:07.786980 · Updated: 2026-03-14T23:03:01.087200