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

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Dentalclean Regenerator Sensitive Dental Gel with Flouride

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.

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 under 6 years of age

Packlabel

DENTALCLEAN REGENERATOR SENSITIVE DENTAL GEL WITH FLOURIDE 
sodium fluoride 0.24% paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84035-002
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)  
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84035-002-031 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(84035-002)

Revised: 5/2024
Document Id: 176aa46a-04c4-4fef-e063-6294a90a1a70
Set id: 176aa3ed-e2a4-536d-e063-6294a90aa097
Version: 1
Effective Time: 20240501
 
Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda