DENTALCLEAN REGENERATOR SENSITIVE KIDS- sodium fluoride 0.24% paste, dentifrice

Dentalclean Regenerator Sensitive Kids by

Drug Labeling and Warnings

Dentalclean Regenerator Sensitive Kids 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 Ingredients

Glycerol, Silium Dioxide, Water, Sorbitol, Sodium Lauryl Sulphate, Carmetlose Sodium, Phosphoric Acid, Aroma, Tetrasodium Pyrophosphate, Cetytpyridinium Chloride, Sodium Benzoate, Titanium Dioxide, Sucralose, D-Limonene.

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 KIDS 
sodium fluoride 0.24% paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84035-005
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)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
GLYCEROL FORMAL (UNII: 3L7GR2604E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
PHOSPHORIC ACID (UNII: E4GA8884NN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84035-005-03	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(84035-005)