DENTALCLEAN REGENERATOR SENSITIVE KIDS- sodium fluoride 0.24% paste, dentifrice 
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda

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Dentalclean Regenerator Sensitive Kids

Sodium fluoride 0.24%

Anticavity

Useaids in the prevention of dental cavities

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


Directions

• 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.

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 under 6 years of age

Packlabel

DENTALCLEAN REGENERATOR SENSITIVE KIDS 
sodium fluoride 0.24% paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84035-005
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84035-005-031 in 1 CARTON06/01/2024
1104 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02106/01/2024
Labeler - Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda (901719567)
Establishment
NameAddressID/FEIBusiness Operations
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda901719567manufacture(84035-005)

Revised: 5/2024
Document Id: 17f3172d-a323-6d68-e063-6394a90a1881
Set id: 17f31b5e-dd3b-78df-e063-6294a90a43ab
Version: 1
Effective Time: 20240508
 
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda