DENTALCLEAN REGENERATOR SENSITIVE DENTAL GEL WITH FLOURIDE- sodium fluoride 0.24% paste, dentifrice

Dentalclean Regenerator Sensitive Dental Gel with Flouride by

Drug Labeling and Warnings

Dentalclean Regenerator Sensitive Dental Gel with Flouride by is a Otc medication manufactured, distributed, or labeled by Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium fluoride 0.24%

PURPOSE

Anticavity

INDICATIONS & USAGE

Useaids in the prevention of dental cavities

WARNINGS

WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.

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.

OTHER SAFETY INFORMATION

Store in a dry, cool place away from sunlight.

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTALCLEAN REGENERATOR SENSITIVE DENTAL GEL WITH FLOURIDE 
sodium fluoride 0.24% paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84035-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCRALOSE (UNII: 96K6UQ3ZD4)
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)
MENTHOL (UNII: L7T10EIP3A)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84035-002-03	1 in 1 CARTON	06/01/2024
1		104 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/01/2024

Labeler - Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda (901719567)

Establishment
Name	Address	ID/FEI	Business Operations
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda		901719567	manufacture(84035-002)